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I got an email from Gail Naughton regarding Histogen Trials


#1

Here was here response to my question about the time frame.

Dear Khalil,

Thanks for your patience.

We are starting phase 1/2 in Singapore before the end of May and hope to have phase 3 pan-Asian data by Sept 2012 for an NDA submission and 2013 approval. (hopefull Q2 2013).

We will be starting to collect info on volunteers shortly.

Please write me in May for an update.

Thanks and take care,

Gail


#2

» Here was here response to my question about the time frame.
»
» Dear Khalil,
»
» Thanks for your patience.
»
» We are starting phase 1/2 in Singapore before the end of May and hope to
» have phase 3 pan-Asian data by Sept 2012 for an NDA submission and 2013
» approval. (hopefull Q2 2013).
»
» We will be starting to collect info on volunteers shortly.
»
» Please write me in May for an update.
»
» Thanks and take care,
»
» Gail

So WTF?? why do we have to wait so long if Phase 3 trials will be done in September 2012?


#3

End of May? What happened to the beginning of February?

» » Here was here response to my question about the time frame.
» »
» » Dear Khalil,
» »
» » Thanks for your patience.
» »
» » We are starting phase 1/2 in Singapore before the end of May and hope to
» » have phase 3 pan-Asian data by Sept 2012 for an NDA submission and 2013
» » approval. (hopefull Q2 2013).
» »
» » We will be starting to collect info on volunteers shortly.
» »
» » Please write me in May for an update.
» »
» » Thanks and take care,
» »
» » Gail

»
» So WTF?? why do we have to wait so long if Phase 3 trials will be done in
» September 2012?


#4

» End of May? What happened to the beginning of February?

Same thing that happened to Fall 2010


#5

You’re right, it was supposed to be the beginning of February, but they have changed the start date again. They change the start date too much. I hope Acell, or something else, cures hair loss sufficiently that we don’t need histogen and then they will have wasted their time and money trying to bring histogen to market at all. These people really are not treating us with respect at all. They change the time frame every time the wind blows.

» End of May? What happened to the beginning of February?
»
»
» » » Here was here response to my question about the time frame.
» » »
» » » Dear Khalil,
» » »
» » » Thanks for your patience.
» » »
» » » We are starting phase 1/2 in Singapore before the end of May and hope
» to
» » » have phase 3 pan-Asian data by Sept 2012 for an NDA submission and
» 2013
» » » approval. (hopefull Q2 2013).
» » »
» » » We will be starting to collect info on volunteers shortly.
» » »
» » » Please write me in May for an update.
» » »
» » » Thanks and take care,
» » »
» » » Gail

» »
» » So WTF?? why do we have to wait so long if Phase 3 trials will be done
» in
» » September 2012?


#6

<>

You tell 'em! The only factor influencing their conduct of clinical trials should be your immediate personal needs. Scheduling, logistics, financing, legal clearances, etc., are just flimsy excuses for their stubborn refusal to instantly gratify your demands.


#7

» <<They change the start date too much. These people really are not
» treating us with respect at all.>>

» You tell 'em! The only factor influencing their conduct of clinical trials
» should be your immediate personal needs. Scheduling, logistics, financing,
» legal clearances, etc., are just flimsy excuses for their stubborn refusal
» to instantly gratify your demands.

I’m sure Histogen have their reasons for the delays… being cash strapped for an extended period of time certainly’s one of them. The scheduling, logistics, and legal clearances you mentioned are equally big concerns.

Having said that, it would be nice if, at least, one of the companies researching hairloss managed to stick to their own schedule. I would consider that a morale boost.


#8

» Here was here response to my question about the time frame.
»
» Dear Khalil,
»
» Thanks for your patience.
»
» We are starting phase 1/2 in Singapore before the end of May and hope to
» have phase 3 pan-Asian data by Sept 2012 for an NDA submission and 2013
» approval. (hopefull Q2 2013).
»
» We will be starting to collect info on volunteers shortly.
»
» Please write me in May for an update.
»
» Thanks and take care,
»
» Gail

A 3 pan Asian data by sept 2012, what does this mean? Can we get it done in 2012 or Q2 2013??


#9

» <<They change the start date too much. These people really are not
» treating us with respect at all.>>
»
» You tell 'em! The only factor influencing their conduct of clinical trials
» should be your immediate personal needs. Scheduling, logistics, financing,
» legal clearances, etc., are just flimsy excuses for their stubborn refusal
» to instantly gratify your demands.

they initially said the start date would be 2010, then changed it to feb 2011 now change it to later in 2011. So doesn’t this mean that this is a mickey-mouse organization that can not get its’ act together? All of these things you mention, Scheduling, logistics, financing, legal clearances, etc., doesn’t it seem like they should have factored these things in, in their original timeline when they said 2010…then after they missed the boat on thta one shouldn’t they have factored all that stuff in when they projected feb 2011? I guess they are not a very professional outfit if they can not get their schedule straight. Also, there is the issue that they could make this stuff available right now because there are countries that do not require all this silly testing. Keep in mind that all they are doing is adding to the skin the same properties that were there when you were younger and your hair was stronger and could resist the damage by DHT. It does not sound like a big health risk to add stuff to your skin that was already there anyway when your sking was younger and stronger. It’s a no-brainer that there will not be any side effects. I think that in the case of histogen these studies are a pointless waste of time. I hope someone else comes up with a cure because I would love to see Histogen bit the bullet of having invested and get nothing for their investment. I’m sick of their delays and I really do not believe that they need to do any studies before selling it. They could start selling it now in some parts of the planet while also doing the studies so they could bring it to market in the united states later. they could do both.


#10

» » <<They change the start date too much. These people really are not
» » treating us with respect at all.>>
» »
» » You tell ‘em! The only factor influencing their conduct of clinical
» trials
» » should be your immediate personal needs. Scheduling, logistics,
» financing,
» » legal clearances, etc., are just flimsy excuses for their stubborn
» refusal
» » to instantly gratify your demands.
»
» they initially said the start date would be 2010, then changed it to feb
» 2011 now change it to later in 2011. So doesn’t this mean that this is a
» mickey-mouse organization that can not get its’ act together? All of these
» things you mention, Scheduling, logistics, financing, legal clearances,
» etc., doesn’t it seem like they should have factored these things in, in
» their original timeline when they said 2010…then after they missed the
» boat on thta one shouldn’t they have factored all that stuff in when they
» projected feb 2011? I guess they are not a very professional outfit if
» they can not get their schedule straight. Also, there is the issue that
» they could make this stuff available right now because there are countries
» that do not require all this silly testing. Keep in mind that all they are
» doing is adding to the skin the same properties that were there when you
» were younger and your hair was stronger and could resist the damage by DHT.
» It does not sound like a big health risk to add stuff to your skin that
» was already there anyway when your sking was younger and stronger. It’s a
» no-brainer that there will not be any side effects. I think that in the
» case of histogen these studies are a pointless waste of time. I hope
» someone else comes up with a cure because I would love to see Histogen bit
» the bullet of having invested and get nothing for their investment. I’m
» sick of their delays and I really do not believe that they need to do any
» studies before selling it. They could start selling it now in some parts
» of the planet while also doing the studies so they could bring it to market
» in the united states later. they could do both.

As long as their release date is still 2013 as they promised, than im okay with the timeline.


#11

Haha, nicely put!

» <<They change the start date too much. These people really are not
» treating us with respect at all.>>
»
» You tell 'em! The only factor influencing their conduct of clinical trials
» should be your immediate personal needs. Scheduling, logistics, financing,
» legal clearances, etc., are just flimsy excuses for their stubborn refusal
» to instantly gratify your demands.


#12

You lives dreaming….we will not have nothing of this company before 2015…. they wake up.


#13

» Here was here response to my question about the time frame.
»
» Dear Khalil,
»
» Thanks for your patience.
»
» We are starting phase 1/2 in Singapore before the end of May and hope to
» have phase 3 pan-Asian data by Sept 2012 for an NDA submission and 2013
» approval. (hopefull Q2 2013).
»
» We will be starting to collect info on volunteers shortly.
»
» Please write me in May for an update.
»
» Thanks and take care,
»
» Gail

So who or what is the NDA ? Is it the drug approval authority is the country where the trials are being conducted or is the the FDA New Drug Application ?


#14

» Here was here response to my question about the time frame.
»
» Dear Khalil,
»
» Thanks for your patience.
»
» We are starting phase 1/2 in Singapore before the end of May and hope to
» have phase 3 pan-Asian data by Sept 2012 for an NDA submission and 2013
» approval. (hopefull Q2 2013).
»
» We will be starting to collect info on volunteers shortly.
»
» Please write me in May for an update.
»
» Thanks and take care,
»
» Gail

The Histogen website under Products => Hair Stimulating Complex states pan Asia approval in 2014.


#15

» » Here was here response to my question about the time frame.
» »
» » Dear Khalil,
» »
» » Thanks for your patience.
» »
» » We are starting phase 1/2 in Singapore before the end of May and hope to
» » have phase 3 pan-Asian data by Sept 2012 for an NDA submission and 2013
» » approval. (hopefull Q2 2013).
» »
» » We will be starting to collect info on volunteers shortly.
» »
» » Please write me in May for an update.
» »
» » Thanks and take care,
» »
» » Gail

»
» So who or what is the NDA ? Is it the drug approval authority is the
» country where the trials are being conducted or is the the FDA New Drug
» Application ?

NDA stands for New Drug Application which is an application for approval by the Food and Drug Administration of a new pharmaceutical compound for introduction to the market.

Basically they have to submit their studies to some regulatory commission in Singapore or whereever to get the green lights for introducing HSC into the market


#16

A HM program starts. Common sense says it’s 7-10+ years away. They announce plans to release sooner and everyone ignores the common sense in favor of the hype. The researchers eventually miss deadline after deadline and wind up taking as long as the original common sense prediction suggested. Everyone calls them incompetent for taking too long.


#17

I dread to see these timelines. Our lives are slipping away with each passing year while we wait for cures that are always 5 years away.


#18

Skeleton crew over there.


#19

Actually it was kind of stupid, much the same as you are kind of stupid because you are both supportive of Histogen’s delays even though you both want Histogen as soon as you can get it. That makes you two pretty stupid.

Plus, the reality is that they could put their treatment into the marketplace anytime they want to. They know it. I know this because I have talked to them on the phone and they have told me as much. They have told me that there are places that do not require any approval process so they definitely know this.

And before you say that they have to make sure it’s safe first, keep in mind that all histogen treatments do is make your skin the same as it used to be when your skin was younger/stronger and could overcome DHT. In other words, all Histogen’s treatment does is make skin revert to having the same stuff that it used to have before. It is common sense that there is no way Histogen’s treatments are going to hurt anyone.

Additionally, as far as these delays go, I see companies schedule clinical trials all the time. Delays do happen, but typically when delays happen that means someone in the company didn’t do their homework. One delay is one thing, but these people have already had 2 or 3 delays. These people are definitely operating in a Mickey Mouse fashion. Your post shows your ignorance of the situation because anyone who knows about these kinds of things knows that multiple delays in these types of situations are not all that common.

» Haha, nicely put!
»
» » <<They change the start date too much. These people really are not
» » treating us with respect at all.>>
» »
» » You tell 'em! The only factor influencing their conduct of clinical
» trials
» » should be your immediate personal needs. Scheduling, logistics,
» financing,
» » legal clearances, etc., are just flimsy excuses for their stubborn
» refusal
» » to instantly gratify your demands.


#20

You’re obviously very intelligent. The people at Histogen are Mickey Mouse and they are really not doing things very professionally. That is not to say that they do not have a promising treatment but they really are failing miserable in the “administration dept.” Administratively speaking, they are a joke.

» You lives dreaming….we will not have nothing of this company before 2015….
» they wake up.