3-5 years for HM: what "insiders" are saying

Stem cell; cell based hair therapy
21

» But with Aderans they should be past that. If they produce a phase#2
» result that indicates anything viable enough to continue funding, then it
» must look good enough to already qualify as valid “proof of concept” and
» then some.

Define “proof of concept”. In humans? In animals? Stage II usually determines both efficacy and safety. Most drugs that fail fail in the second round of trials.

22

» » But with Aderans they should be past that. If they produce a phase#2
» » result that indicates anything viable enough to continue funding, then
» it
» » must look good enough to already qualify as valid “proof of concept”
» and
» » then some.
»
» Define “proof of concept”. In humans? In animals? Stage II usually
» determines both efficacy and safety. Most drugs that fail fail in the
» second round of trials.
Stage I proves safety.

23

HM will be here too late for many of you to get back their lives and live happily.

fortunately there are alternatives now. u dont need hm to live happy life.

my prediction is 5 years for aderans to disapoint.
more than 7 years for anything good enough.
there is some chance that we wont see a solution in our life time, but its quite small imho.

24

» » » But with Aderans they should be past that. If they produce a phase#2
» » » result that indicates anything viable enough to continue funding,
» then
» » it
» » » must look good enough to already qualify as valid “proof of concept”
» » and
» » » then some.
» »
» » Define “proof of concept”. In humans? In animals? Stage II usually
» » determines both efficacy and safety. Most drugs that fail fail in the
» » second round of trials.
» Stage I proves safety.

Yeah, and so does Stage II: “Once the initial safety of the study drug has been confirmed in Phase I trials, Phase II trials are performed on larger groups (20-300) and are designed to assess how well the drug works, as well as to continue Phase I safety assessments in a larger group of volunteers and patients.”

I’m flattered by your obsession with me. I bet you read every one of my posts. “Oh! There’s a Fckhrls post! I can’t wait to figure out a way to get him to acknowledge me!”

25

» HM will be here too late for many of you to get back their lives and live
» happily.
»
» fortunately there are alternatives now. u dont need hm to live happy
» life.
»
» my prediction is 5 years for aderans to disapoint.
» more than 7 years for anything good enough.
» there is some chance that we wont see a solution in our life time, but its
» quite small imho.

and, who are you?

26

Define “proof of concept”. In humans? In animals? Stage II usually determines both efficacy and safety. Most drugs that fail fail in the second round of trials.

I’m not sure that you & I are actually disagreeing about anything here.

I do not think we should believe that a valid “proof of concept” has already been achieved just because Aderans is willing to attempt a phase#2.

I am only saying that if they deem their phase#2 results sufficently good to move on to do phase#3, THEN we can probably assume they have produced something good enough to call it “proof of concept.”

27

» I am only saying that if they deem their phase#2 results sufficently good
» to move on to do phase#3, THEN we can probably assume they have
» produced something good enough to call it “proof of concept.”

Absolutely. Most drugs that fail do so in Stage II because their efficacy or safety wasn’t up to snuff. If something moves into Stage III, it signifies that, at least with regards to efficacy, it works. Stage II is by far the most critical stage of the process.

28

» » HM will be here too late for many of you to get back their lives and
» live
» » happily.
» »
» » fortunately there are alternatives now. u dont need hm to live happy
» » life.
» »
» » my prediction is 5 years for aderans to disapoint.
» » more than 7 years for anything good enough.
» » there is some chance that we wont see a solution in our life time, but
» its
» » quite small imho.
»
» and, who are you?

im a former hairsite addict who spent way too many years of his life worrying about ridiculous stuff. Im one of the more pessimistic guys here, but I was so far almost always correct. I did a mistake once, when i was too optimistic.

The idea behind correct predictions is that you cannot violate known rules, regulations, and laws. If your prediction violates these, then u are going to be wrong most probably in your prediction.

The 10 year trial length (10 its according to wikipedia) rule is one of the quite important rules. Aderans is in phase II, thats why i give it optimistic 5 years. I do not think aderans will be a straightforward cure. The probability of it failing is now higher of succeeding (thats again just statistics, most products in phase II never reach the market). And If it succeeds, then all you can expect in the best scenario is limitless donor hair (thats based on the knowledge of their product). Skill of the surgeon, and countless amount of procedures and touchups will be a must for a good looking result.

Everything else is way above that 5 year mark.

Like it or not, but this is how this reality is set up.

29

» » I am only saying that if they deem their phase#2 results sufficently
» good
» » to move on to do phase#3, THEN we can probably assume they have
» » produced something good enough to call it “proof of concept.”
»
» Absolutely. Most drugs that fail do so in Stage II because their efficacy
» or safety wasn’t up to snuff. If something moves into Stage III, it
» signifies that, at least with regards to efficacy, it works. Stage II is
» by far the most critical stage of the process.

Well, Phase II success is not a total guarantee of success. Look at ICX-PRO. When they ran Phase III trials, the FDA said NO WAY. I wonder if Phase II results were falsified?? I don’t remember, but its possible that PhaseII trial was done in the UK, whith the local authorities being more optimistic about the results, and PhaseIII trial was done in the USA with a more severe FDA judgement.??? no?
Its very weird that after successfully completing Phase II, they failed PhaseIII. If my memory serves, in PhaseIII, ICX Pro had no better results than the conventional treatment for VLUs (conventional tretment= compression bandages)regarding total wound closure.

30

Yes there are some evident truths here such as 10 years being a good timeline for FDA approval. And with Aderans being in the middle of Phase 2 then 5 years certainly isn’t impossible.

However, I read somewhere that only 10% of things get through Phase 1 and 2 to actually progress into Stage 3 - they either don’t work or there are safety issues or they DON’T WORK WELL ENOUGH.

If it only grows peach fuzz or it’s “twice as good as Fin” or it grows nothing then we’re back to the starting blocks. Even if it gets “coverage” type hair it might not progress as it may not be finacially viable even if the science is sound. And if its unsafe we’re back to the starting blocks, of course.

But IF it works, then 5 years IS perfectly reasonable. Especially if it works well and investors sniff huge profits and pile in the cash and political pressure. Of course those are big ifs … one that can only become more than conjecture if one knows enough about their researchers, their funding and the science involved. Then it becomes less of a gamble - but still a gamble nonetheless.

Basically, it’s a coin toss. If it works as we (and they) want, then 5 years is no pipe dream.

If it doesn’t, then we’re in the same position as now. That’s pretty much where we stand now.

31

I mostly agree about that. I’m not saying that phase#2 is proof that it can’t be rejected later on, I’m just saying that it tells us something worked to some extent.

And honestly, if something works then it will probably see the light of day somewhere, somehow. Maybe in an unregulated country instead of the USA or UK, but it’ll get out.