Neosil phase two study RESULTS from Germany

I hate to be a bearer of bad news, but that hair count increase and thickness increase isn’t as good as minoxidil’s…this isn’t going to be revolutionary or anything like that. I dont know if its even worth pursuing further. 4.8% increases in hair counts at 24 weeks just isn’t much if a guy is very thin on top. 3.7 percent increases in thickness…just aint much. Like Ive said, we need something that will put NEW hair up there

FOR IMMEDIATE RELEASE Click Here for Our Nov. 8th 2004 Press Release

NEOSIL ANNOUNCES POSITIVE PHASE 2 DATA FOR NEOSH101, AN INVESTIGATIONAL TREATMENT FOR ANDROGENETIC ALOPECIA

Emeryville, CA – January 4, 2007 – Neosil, Inc., a privately held dermatology-focused pharmaceutical company, today announced positive Phase 2a clinical data demonstrating that its lead product, NEOSH101, increased hair growth significantly in men diagnosed with androgenetic alopecia, also known as pattern hair loss (PHL). Androgenetic alopecia or PHL, caused by a combination of genetic and hormonal factors, is noticeable in about 20 percent of the population by age 20 and increases steadily with age. By age 50 approximately half of the U.S. population will have some degree of PHL. “

Based on the results of this study, we are quite encouraged by the increase in hair growth observed after such a short once-daily treatment regimen with NEOSH101,” said Vera H. Price, MD, FRCP(C), Professor of Clinical Dermatology, Department of Dermatology, University of California, San Francisco.

In a randomized, double-blind Phase 2a clinical study, conducted in Germany, 50 men with androgenetic alopecia (Norwood/Hamilton grades III-IV) received once-daily topical treatments of NEOSH101 or placebo over two 14-day treatment periods, which were separated by a one-month drug-free interval. Hair growth was measured using an objective photographic, computer-based analysis for up to 24 weeks after initiation of therapy. Results show that NEOSH101 was safe and well tolerated. A statistically significant increase in total hair count (4.8%, p=0.04), and cumulative hair thickness (3.7%, p=0.02) were observed, with peak effects occurring eight weeks following the second treatment cycle.
“The results of this study are encouraging, particularly the finding of increased numbers of terminal hairs, those hairs that are thicker than 40 microns and desirable for scalp coverage,” said Andria Langenberg, M.D., Vice President of Clinical Development at Neosil. “We plan to initiate a Phase 2b study to evaluate daily treatment with NEOSH101 for a longer treatment period in men with PHL.”

About Neosil

Neosil, Inc. is a privately held dermatology-focused pharmaceutical company that was funded in November 2004 with a $32 million investment by MPM Capital and Burrill & Company, following initial incubation funding by Shalon Ventures, LP. In addition to its topical hair growth product, NEOSH101, Neosil is developing a broad-spectrum topical anti-microbial agent for acne and anti-infective use.

CONTACT:

Neosil, Inc.
ATTN: Eugene Bauer, M.D.
5980 Horton St., Suite 525
Emeryville, CA 94608
510-547-3610
510-547-3604 fax
info@neosil.com

Click Here for Our Nov. 8th 2004

IM not very enthused about that at all…the date on the release is January of 2007, which is last year…but its news to me. I haven’t followed neosil because I just dont think any therapy that is made to make existing follicles “bigger” is a long term answer unless they unlock EXACTLY what the immune system attacks about the follicle. The news that follicles lose a molecule, CD200, that tells the immune system not to attack a given organ, makes me less enthusiastic such a thing is possible. What we need is NEW hair–in my opinion.

That sucks. However, they did cycle the treatment (2 weeks on/4 weeks off). It sounds as if they are going to continue the trial was a consistent application. That may change the results slightly.

I’ll say this, though - its nice to see a REAL press release, with real data and a real explination of method. For those who don’t know the difference, that is how the ICX press release SHOULD have looked.

Got this from another website:

"What is your opinon on the findings based on only two 14-day treatment periods? Significant? (Increase in total hair count of 4.8% and cumulitive thickness of 3.7%).

Hypothetically speaking, if there is on average in and around 150,000 hairs on the human scalp and one were to be suffering from hairloss and lost say 50,000 hairs and had 100,000 current hairs and were to receive an increase of 4.8%, that would be around an increase of 5,000 hairs, which is equivalent to an average HT procedure on a N4 or N5 jumping 2-3 NW scales.

Or for arguments sake, if we even took the numbers down to 50,000 hairs remaining on the scalp in total and there was a 4.8% increase in total hair count, we would be looking at an increase of 2,500 hairs which again, would be comparable to jumping at least 1 NW scale.

Again, these are just hypotheticals as a lot more needs to be proven in regards to averages, consistency and areas of the scalp that respond (does the frontal area respond or is it more like fin and minox and only respond moderately well through the anterior region and crown). These initial findings were based on small test areas not entire scalps. The results from Phase IIb will tell us a lot"

PS- Benji, youre on a real negative trip lately. it seems like your lookin to just find anything and everything to tear down.

the regrowth rate is terribly low, but I wonder:

  1. Is regrowth accumulative per repeat applications (over time of course)?
  2. Does it work in the frontal area (because rogaine does not)?

.

Nizoral usage over six months showed a more than 6% increase in hair counts…

The treatment schedule for the Neosil study was:

14 days on
One month off
14 days on
Two months off
Haircounts reach their “peak”
Two more moths—end of study.

Duration is 24 weeks or six montths. Highest haircount was at four months—which was two months past the last treatment date. Obviously they dont think it best to apply this stuff everyday (which may be because they are worried about safety or maybe because they think it wont do any more good to do so), but I will say this…Nizoral upped the anagen percentage by over 6%

Hell, Fluridil upped the anagen percentage from 77 to 85%, which is over a 10% increase in anagen hairs—and it no doubt made the hairs larger in circumference.

Here is one nizoral study:

Nizoral 1% Study
The effects of chronic use of 1% ketoconazole or a 1% zinc pyrithione shampoo on the general health of hair and scalp.

G. Piérard 1and G. Cauwenbergh2

  1. Dept Dermatopathology, University of Liège, Belgium; 2. Skin research Center, Johnson &Johnson , Skillman, N.J., USA

Hundred male volunteers with mild to moderate dandruff and somewhat oily scalp, have used, in a double-blind fashion, a 1% ketoconazole shampoo or a 1% zinc pyrithione shampoo. The test shampoos were applied 2 to 3 times weekly for a total period of 6 months. Several parameters that affect the general health of hair and scalp were assessed at start, and after 1, 3 and 6 months. These parameters included the percent of hairs in anagen phase, the diameter of the hairs, sebum excretion rate at the hairline, and the number of hairs shed in the 24-hour period prior to each assessment. At the end of the study, the participants were asked to complete a questionnaire regarding the cosmetic acceptability of the test shampoos.

Forty-four ketoconazole users and forty-three zinc pyrithione users completed the 6 month study period. Analysis of the different parameters shows that the hair diameter gradually increases with chronic ketoconazole use (+8.46%) over a 6 month period, whereas the diameter shows a trend to decrease with zinc pyrithione use over the same period (-2.28%). The sebum excretion rate is reduced with ketoconazole (-6.54%) while it increases with zinc pyrithione (+8.2%) over the same period of time. The number of hair shed over a 24-hour period is reduced by 16.46% with ketoconazole and 6.02% with zinc pyrithione after 6 months. Finally, the percentage hairs in anagen phase increased by 6.4% and 8.4% respectively during the study time. Except for the percentage of hairs in anagen, which showed no difference between the two groups, all other parameters were significantly different in favor of the ketoconazole shampoo.

Both shampoos have been shown to be good anti-dandruff ingredients. Assessment of parameters than can affect the health of hair and scalp, suggests that both ingredients show distinct differences in the way they affect the scalp; indicating that ketoconazole increases hair diameter and reduces scalp oil, whereas zinc pyrithione seems to yield opposite effects. This suggests that, besides their effect on the lipophilic yeast Malassezia spp, ketoconazole and zinc pyrithione act though quite different mechanisms. An overall analysis of hair diameter changes as a function of changes in sebum excretion rate suggests that a reduction in scalp oiliness seems to result in an increased hair diameter. This suggests that, in people with oily hair, regular use of ketoconazole shampoo may result in overall hair fullness.

They do haircounts and haircount increases via “areas” of the scalp. The donor-area hairs are going to remain unchanged. The percentage increases were no doubt “in the balding area” only, and probably per square inch to be honest. If you think this gave these men 5000 “new” hairs, you will probably be very very very dissapointed.

Even if it IS a great stimulant…that doesnt mean the effect lasts for years and years. The initial increase in haircounts is good with 5% minoxidil, but it peaks at about the two year mark and starts to decrease afterwards, and it decreases more sharply than finasteride does…way more sharply.

Here is a minoxidil study replete with pictures you can look at:

I honestly doubt, if you look at the minox study, that you will be impressed with Neosil. It probably isn’t as effective as minoxidil.

They have a new study in progress (or it recently completed). They have not published those results yet, as far as I know. A couple of things are different about the latest trial:

  1. They are now testing a range of doses. So higher doses are being tested.
  2. Daily application for the entire trial (instead of the on/off schedule).

The results should come out soon, hopefully.

» They have a new study in progress (or it recently completed). They have not
» published those results yet, as far as I know. A couple of things are
» different about the latest trial:
»
» 1) They are now testing a range of doses. So higher doses are being
» tested.
» 2) Daily application for the entire trial (instead of the on/off
» schedule).
»
» The results should come out soon, hopefully.

Yes, lets just wait for the results of the curent trial before we assign Neosil a big F for failure.

Saying something will be disappointing or a failure by looking at the results from an earlier phase of trial that involved lower dosages and less applications doesn’t make sense to me.

» I’ll say this, though - its nice to see a REAL press release, with real
» data and a real explination of method. For those who don’t know the
» difference, that is how the ICX press release SHOULD have looked.

Agreed, 100%.

A lot of forum members seem to have either forgotten or abandoned our former skeptical/antagonistic and inquisitive approach toward anyone or any organization proclaiming to have found the “cure”, or knowing of someone who has. If a sensible, concrete theory based on scientific priniciples was not presented, the would-be “cure deliverer” would be rightfully dismissed by the veterans on this board. If a sensible theory was provided, we’d eventually want to see results (eg., pictures), or again, the would-be “cure deliverer” would lose credibility.

This has been our way of weeding out the snake oil salesmen and preventing our brethern from being misled or taken advantage of. It has been (or at least was) one of the greatest qualities of this board. Of late, it appears the new philosophy has been “if you don’t have anything nice to say, don’t say anything at all”, which perpetuates deception.

This is a real shame.

» » I’ll say this, though - its nice to see a REAL press release, with real
» » data and a real explination of method. For those who don’t know the
» » difference, that is how the ICX press release SHOULD have looked.
»
» Agreed, 100%.
»
» A lot of forum members seem to have either forgotten or abandoned our
» former skeptical/antagonistic and inquisitive approach toward anyone or
» any organization proclaiming to have found the “cure”, or knowing of
» someone who has. If a sensible, concrete theory based on scientific
» priniciples was not presented, the would-be “cure deliverer” would be
» rightfully dismissed by the veterans on this board. If a sensible theory
» was provided, we’d eventually want to see results (eg., pictures),
» or again, the would-be “cure deliverer” would lose credibility.
»
» This has been our way of weeding out the snake oil salesmen and preventing
» our brethern from being misled or taken advantage of. It has been (or
» at least was) one of the greatest qualities of this board.
Of late,
» it appears the new philosophy has been “if you don’t have anything nice to
» say, don’t say anything at all”, which perpetuates deception.
»
» This is a real shame.

You still don’t get it. ICX has never once said the project was cancelled or they failed. Somehow you are not happy unless the board is perpetuated with false rumors that they failed.

All I am trying is to encourage discussions based on FACTUAL information. You obviously have something different in mind.

If you have to continue to post irresponsibly and encourage others to spread false rumors and unsubstantiated allegations, please do NOT post at all.

There is a huge difference between seeking a partner and cancelling a project. If you can’t tell the difference, please stay away from this forum.

» » » I’ll say this, though - its nice to see a REAL press release, with
» real
» » » data and a real explination of method. For those who don’t know the
» » » difference, that is how the ICX press release SHOULD have looked.
» »
» » Agreed, 100%.
» »
» » A lot of forum members seem to have either forgotten or abandoned our
» » former skeptical/antagonistic and inquisitive approach toward anyone or
» » any organization proclaiming to have found the “cure”, or knowing of
» » someone who has. If a sensible, concrete theory based on scientific
» » priniciples was not presented, the would-be “cure deliverer” would be
» » rightfully dismissed by the veterans on this board. If a sensible
» theory
» » was provided, we’d eventually want to see results (eg.,
» pictures),
» » or again, the would-be “cure deliverer” would lose credibility.
» »
» » This has been our way of weeding out the snake oil salesmen and
» preventing
» » our brethern from being misled or taken advantage of. It has been
» (or
» » at least was) one of the greatest qualities of this board.
Of
» late,
» » it appears the new philosophy has been “if you don’t have anything nice
» to
» » say, don’t say anything at all”, which perpetuates deception.
» »
» » This is a real shame.
»
» You still don’t get it. ICX has never once said the project was cancelled
» or they failed. Somehow you are not happy unless the board is perpetuated
» with false rumors that they failed.
»
» All I am trying is to encourage discussions based on FACTUAL
» information
. You obviously have something different in mind.

Yes, but at the moment the problem is that WE DON’T HAVE FACTUAL INFORMATION to speak about nothing, on icx, and in this situation it’s clear that people speak bad about them, if tou don’t know nothing you are naturally stimulated to speak bad… i hope that they understand this and do a new report, or an official interview where they speak about the real situation of the trc.

» Yes, but at the moment the problem is that WE DON’T HAVE FACTUAL
» INFORMATION to speak about nothing, on icx, and in this situation it’s
» clear that people speak bad about them, if tou don’t know nothing you are
» naturally stimulated to speak bad… i hope that they understand this and
» do a new report, or an official interview where they speak about the real
» situation of the trc.

That is fair if you feel that the press release is too vague, it lacks statistics, no before and after photos. That is the truth. Nobody can fault you for that. But it is unacceptable to go from the press release being vague to outright claim that they are cancelling the project.

» » Yes, but at the moment the problem is that WE DON’T HAVE FACTUAL
» » INFORMATION to speak about nothing, on icx, and in this situation it’s
» » clear that people speak bad about them, if tou don’t know nothing you
» are
» » naturally stimulated to speak bad… i hope that they understand this
» and
» » do a new report, or an official interview where they speak about the
» real
» » situation of the trc.
»
» That is fair if you feel that the press release is too vague, it lacks
» statistics, no before and after photos. That is the truth. Nobody can
» fault you for that. But it is unacceptable to go from the press release
» being vague to outright claim that they are cancelling the project.

stop a research or don’t say nothing about that, in a public report, for me is the same. If you don’t say nothing, maybe is because you don’t have nothing to say! So, people are not stupid, if in a report with 4 products you say a lot about all, and nothing about one, maybe is because the research ig going bad! I hope i’m not sayng the truth, but at the moment this is the only thing that someone can think…

» » » Yes, but at the moment the problem is that WE DON’T HAVE FACTUAL
» » » INFORMATION to speak about nothing, on icx, and in this situation
» it’s
» » » clear that people speak bad about them, if tou don’t know nothing you
» » are
» » » naturally stimulated to speak bad… i hope that they understand this
» » and
» » » do a new report, or an official interview where they speak about the
» » real
» » » situation of the trc.
» »
» » That is fair if you feel that the press release is too vague, it lacks
» » statistics, no before and after photos. That is the truth. Nobody can
» » fault you for that. But it is unacceptable to go from the press
» release
» » being vague to outright claim that they are cancelling the project.
»
» stop a research or don’t say nothing about that, in a public report, for
» me is the same. If you don’t say nothing, maybe is because you don’t have
» nothing to say! So, people are not stupid, if in a report with 4 products
» you say a lot about all, and nothing about one, maybe is because the
» research ig going bad! I hope i’m not sayng the truth, but at the moment
» this is the only thing that someone can think…

ICX last announcement said the following:

  1. All current trialists have been treated.
  2. We will collect all data, at the end of the current trial.
  3. We are seeking a partner to conduct phase III on a large scale.

Why would they give out hair counts, pictures, detailed analysis at this stage, when they said data wont be analyzed until the end the current phase?
They are halfway through the current phase and have just completed the treatment stage.
Its like a patient just getting a series of TRC injections today and every one on here expecting full detailed data/analysis on regrowth a few days later!

They said that they have treated all the trialists they need to for this particular stage and will collect all data at the end of the current phase.

The announcement on the 18th was just to let us know all necessary trialists have been treated and what they plan to do as the next step.

Very little has changed since their last update, people were expecting far to much from the announcement.

“02) Does it work in the frontal area (because rogaine does not)?”

Oh, really? Is this from personal experience? The notion that minoxidil does not work in the hairline comes from speculation about the fact that Upjohn originally submitted data to the FDA that showed only the vertex being treated by Rogaine. Since Upjohn did not submit studies related to hairline efficacy, they could not claim that Rogaine would work on the hairline. Minoxidil should work equally well regardless of location of application.

»
» You still don’t get it. .

No–I think it is you who doesn’t get it; or you are confusing my posts with other users. I have consistently complained about how the report is vague and basically says nothing except wait some more, after we already waited months since their last report, which also didn’t provide any specific information. In my eyes, based on past experiences of this board, this has to result in diminished credibility.

ICX has never once said the project was cancelled
» or they failed. Somehow you are not happy unless the board is perpetuated
» with false rumors that they failed

This is wholly unfounded–I have never stated that they failed or that the project was cancelled. We weren’t provided enough information in the report to make this determination. In fact, the report would lead the average person to believe they are doing well–well enough to hook up with a bigger player. But if this is true, then my gripe is why can’t they do like Neosil, and break it down for us with a little more depth. Why are they being so open about all of their other products (eg., before and after pictures showing wound healing), but not TRC?

My unhappiness with the board doesn’t stem from the perpetuation of false rumors; it stems from the vagueness of ICX’s report and in my eyes, ICX’s ensuing and unfortunate loss of credibility. I’m also disappointed that you would edit and delete my observations in this regard, but so readliy tolerate and permit some of the garbage and complete nonsense that other posters regularly spew on this board.
»
» All I am trying is to encourage discussions based on FACTUAL
» information
. You obviously have something different in mind.
»

This is what I’m complaining about: they didn’t provide any real factual information. Hence, they shouldn’t be taken as seriously as before. We’re all familiar with the idioms: “Sh-t or get off the pot”, “the proof is in the pudding”, etc. What’s the point in telling everyone “there’s an update on the way” which basically says nothing other than “there’s another update on the way”

» If you have to continue to post irresponsibly and encourage others to
» spread false rumors and unsubstantiated allegations, please do NOT post at
» all.»

» There is a huge difference between seeking a partner and cancelling a
» project. If you can’t tell the difference, please stay away from this
» forum.

Again, I think you got the wrong guy–this hasn’t been my position.

I think after the ICX report, it is unavoidable that, in the forum, there is a mixture of pessimism and optimism.
Trying to censor any of them is absurd.
ESP is a long-term forum member, and he should be treated accordingly.

Confussion at this point is logical.
If negative speculation is wrong, ICX has it very easy: just email David to explain what is really happening.

Anyway, I think, right now, ICX has no idea of what is going to happen to TRC.
They need a partner, and right now they don’t know if there is going to be one. It will depend on the full set of results from phaseII.

The matter is that ICX is not clear -I think they will it - and is not congruent with they said in the past:

  1. percentage of injection for resident hairs and they don’t give the resident hairs! this datum doesn’t mean anything!! how many resident hairs were there??? 15??? and 105% does mean 15-20 hairs more??? ->

  2. no more numerical results are reported in march 08

  3. 66 new hairs in phase I (safety) and only 15-20 hair in phase II (efficacy)??? strange!

  4. where is the small -at short term- commercialization of TRC??

  5. Bosley was a partner only for distribution, not for the development in phase III of TRC.

ALL THESE INFORMATIONS COME FROM INTERCYTEX.

» »
» » You still don’t get it. .
»
» No–I think it is you who doesn’t get; or you are confusing my posts with
» other users. I have consistently complained about how the report is vague
» and basically says nothing except wait some more, after we already waited
» months since their last report, which also didn’t provide any
» specific information. In my eyes, based on past experiences of this
» board, this has to result in diminished credibility.
»
» ICX has never once said the project was cancelled
» » or they failed. Somehow you are not happy unless the board is
» perpetuated
» » with false rumors that they failed
»
» This is wholly unfounded–I have never stated that they failed or that the
» project was cancelled. We weren’t provided enough information in the
» report to make this determination. In fact, the report would lead the
» average person to believe they are doing well–well enough to hook up with
» a bigger player. But if this is true, then my gripe is why can’t they do
» like Neosil, and break it down for us with a little more depth. Why are
» they being so open about all of their other products (eg., before and
» after pictures showing wound healing), but not TRC?
»
» My unhappiness with the board doesn’t stem from the perpetuation of false
» rumors; it stems from the vagueness of ICX’s report and in my eyes, ICX’s
» ensuing and unfortunate loss of credibility. I’m also disappointed that
» you would edit and delete my observations in this regard, but so readliy
» tolerate and permit some of the garbage and complete nonsense that other
» posters regularly spew on this board.
» »
» » All I am trying is to encourage discussions based on FACTUAL
» » information
. You obviously have something different in mind.
» »
»
» This is what I’m complaining about: they didn’t provide any real
» factual information.
Hence, they shouldn’t be taken as seriously as
» before. We’re all familiar with the idioms: “Sh-t or get off the pot”,
» “the proof is in the pudding”, etc. What’s the point in telling everyone
» “there’s an update on the way” which basically says nothing other than
» “there’s another update on the way”
»
» » If you have to continue to post irresponsibly and encourage others to
» » spread false rumors and unsubstantiated allegations, please do NOT post
» at
» » all.»
»
» » There is a huge difference between seeking a partner and cancelling a
» » project. If you can’t tell the difference, please stay away from this
» » forum.
»
» Again, I think you got the wrong guy–this hasn’t been my position.

I agree 100% with ESP.

HairSite ,you’ve deleted some post of mine,too;
i’m sure of your good faith;

but the most of people here want only clear news about the status of TRC.

Very sensitive information has come to us ONLY for a MAIL that someone have posted.

Think about the percentage regrowth and how are calculated.
Where an investor can read in ** ufficial report ** ?
We see only confusing statement like “105% regrowth”.

And NO, what we can read in one of last email from icx,
IT’S NOT ALL what we can read in press release.

Press release :
We DO NOT intend to finance bla bla bla

Email :
To clarify we plan to finish the current Phase II trial and collect all the data. We also plan to continue our preclinical work. For the next clinical trial we believe this would best be carried out in partnership with a specialist in the field. It is normal for Biotech Companies of our side to seek partnerships to fund later stage clinical trials.

**We do not believe the overall progress of the project will be impacted.

More or less same meaning …OK.
But sound s quite different !

  1. “To clarify we plan …” …
    A company cannot use misunderstanding term or state in offical report
    and THEN send a mail to SOMEONE to clarify.

2)“We do not believe the overall progress will be impacted” but also
"we do not intend to finance" …
so 2 + 2 equal 4 and if NO PARTNER - NO PARTY.

Also i miss phase I data ( 66 NEW HAIR!!! ) in official report, but for this
i have trusted in your interview with Kemp.

At this time i would be very interested to read WITH MY EYES the results in a PDF .

I hope you could understand what i mean.

I’m agree also with people who want a new interview with Kemp or something like a CLEAR direct contact .

This is a very important thing ,for all us.

Please HairSite, let we know …

» The matter is that ICX is not clear -I think they will it - and is not
» congruent with they said in the past:
»
» 1. percentage of injection for resident hairs and they don’t give the
» resident hairs! this datum doesn’t mean anything!! how many resident hairs
» were there??? 15??? and 105% does mean 15-20 hairs more??? ->
»
»
» 2. no more numerical results are reported in march 08
»
» 3. 66 new hairs in phase I (safety) and only 15-20 hair in phase II
» (efficacy)??? strange!
»
» 4. where is the small -at short term- commercialization of TRC??
»
» 5. Bosley was a partner only for distribution, not for the development in
» phase III of TRC.
»
» ALL THESE INFORMATIONS COME FROM INTERCYTEX.

I agree 100% here too.
HairSite read my other post on this thread.

“02) Does it work in the frontal area (because rogaine does not)?”

Oh, really? Is this from personal experience? The notion that minoxidil does not work in the hairline comes from speculation about the fact that Upjohn originally submitted data to the FDA that showed only the vertex being treated by Rogaine. Since Upjohn did not submit studies related to hairline efficacy, they could not claim that Rogaine would work on the hairline. Minoxidil should work equally well regardless of location of application.

Nope, never tried it. Having said that, Rogaine was introduced into the market when? 20 years ago? You’d think the company would perform a small study within that timeframe to end the speculation.

.