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  1. #41
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    So only people left are Follica and Histogen, given Replicel got disappointing results and has a questionable process...

  2. #42
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    Quote Originally Posted by Desmond84 View Post
    Thinning I'm no longer emotional about the cutting edge but objective. The last 12 months have thought me a lot about hairloss and our options. Having spent some years in clinical trial design I can assure you about how things generally unfold with trials.

    Companies conducting trials ALWAYS have to make a 'go' or 'no go' decision as they receive their interim trial results as to whether continue with the next phase or not. Generally, if the interim results are solid as was Histogen's back in October 2012, they immediately start to work on the next phase (writing up draft protocol, etc) while the initial trial is still ongoing. This usually leads to a 3-4 month downtime until the next phase starts. Every 'Clinical Research Associate' I know always says "Time is money" as the longer you spend on trials the shorter the patent period will be that you actually have your product on the market! Time management and efficiency is integral to a successful drug approval.

    Think about Aderans for example. They conducted 11 Phase 2 trials in 5 years! It would have been impossible to conduct so many trials in 5 years, if they waited 6 months to analyse each final results and another 6 months to write up the protocol for the next Phase 2 trial. If so, it would have taken them over 30 years to finish these 11 trials!

    Replicel is another great example that everyone is aware of. Their Phase 2a finishes in Dec 2013 and Phase 2b begins in Jan 2014! They started working on Phase 2b well before Phase 2a ended.

    Histogen had a clear picture of their product's efficacy back in October 2012, however we now know that they didn't start acting on this information to plan for the next Phase ASAP. The reasons are only known to Gail and her team and anything we say is speculation. But the facts remain that Histogen will most probably not initiate any trials in 2013.

    This leaves the hairloss sufferers in a difficult position as there is no clear picture of product release date or even further delays. So, we would be doing our friends in BTT a huge de-service by giving them false hopes and stopping them from making an integral decision to do something about their hair now rather than in the future.

    I just don't want anyone looking back on these days with hindsight and say I wish I didn't wait for these treatments and did something for my hair when I had the chance!
    I am not questioning all the difficulties and obstacles that are and will be encountered in the industry by the companies we all want to see succeed.

    I am saying the 6-9 months period of reading data and trying to comply to FDA standards (which you call "taking time off") is not only something we all knew about in the past, but you are the very one person that was taking it into account in the past when making deadlines.

    Nothing has changed, for all we know Histogen is still the same company it was six months ago with the same deadlines. So the whole "I am switching from positive to neutral" thing makes no sense because no offense it's just moodrings due to what seems lack of progress but really is lack of news.

    And I completely understand being pissed off for all this, because I am also bitter to say the least, but let's not give in to our emotions by creating new opinions based on nothing else other than emotions every two months.

    If anything, it's not the optimism, but the volatility of the forum that hurts younger crowds new to the threads.

    We have had an awesome month of June, totally unexpectedly since we initially hadn't heard anything from the congress in May; I don't need to explain why.

    Hang in there people, progress is obviously being made, relax and focus on other aspects of your lives, stuff will eventually come out.

  3. #43
    Senior Member Pentarou's Avatar
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    Quote Originally Posted by KO1 View Post
    So only people left are Follica and Histogen, given Replicel got disappointing results and has a questionable process...
    Well, to be fair, their results were good enough to go to the next phase of trials.

    Isn't Replicel's treatment approach similar but different to Aderans, incidentally?

  4. #44
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    Aderans believed in using both dermal and epidermal cells - fibroblasts and keratinocytes, whereas Replicel just uses one cell type - DSC fibroblasts. I think ARI's process was better...and I think that is what Nigam is moving towards.

  5. #45
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    How long do you think Dr Nigam will need for his treatment?

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