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What happens if....., page-2

  1. 4,436 Posts.
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    Ok let me say a few words on your point 3.

    If it were a company that only had OA solution and nothing else, then yes, a failure of Phase three wouldn't be great and would cause the SP to go close to zero, if not zero.

    However, there are a few things with us....

    1) We don't just have OA that we are going for, although this is by the far the biggest and most important indication we are pursuing.

    2) Once a company gets through their Phase two sucessfully then it does depend on what the end points are for Phase three, in our case they are virtually the same. We got good results in Phase two and there shouldn't be any reason we actually fail Phase three.
    Yes there is a small chance that could happen, though I can't see how. A company that has borderline success in Phase two would have a higher chance of failure in Phase three due to the sheer numbers. That's what a Phase three is primarily about, 'safety in numbers' as it were. Instead of hundreds, we are dealing with thousands. A typical P3 usually has upwards of 3000 patients, we have it good with some 1150 odd.



    3) Yes I have experienced a failure of a company that were conducting clinical trials, namely Sirtex which I have posted on a couple of occasions. Despite this failure they ended up doing ok and eventually getting a decent take over deal which they accepted 1.
    Again our situation is totally different and it is difficult to draw many parallels with others. We are in a unique situation, hey, just the fact that we appear to have a Disease Modifying OA Drug is in itself sit-up-and-take-note worthy!

    I can't tell you what's going to happen in the future, I can't guarantee anything and I know you aren't expecting me to. Sure a failure in Phase three wouldnt be wonderful but as I say, can't see it happening. We have great management, very good competentant and dedicated staff and we have some of the world wide best experts in OA on our side, working on our team...heard of Donald Bradman? Heard of Babe Ruth? We have one better (click on this hyperlink ----> Dr D Felson ) we have so much research behind us with so many other wonderful trials in animals and humans that have been a total success. We have NO AE's...not one. We have durability and we have a meaningful and statistically relevant drop in pain levels. We are fully funded, we have a water tight supply and we have decent patents in place.

    Hmm another chance at a clinical trial after a potential failure? Yes maybe, the classic example is Hay Fever, we ourselves failed Phase 2 but it certainly ain't over, there is much to be done to see what happened and how to restructure this one to 'resit' the exam....but I know for a fact there is a least some patients that achieved amazing results in this area due to our drug. I suspect it was the method of delivery, think bio availability... That particular chapter is in no way over.

    I hope that adds some colour to your thinking without this being advice. Always best to DYOR.

    References
    1] https://www.drugdeliverybusiness.com/sirtex-sir-spheres-fail-meet-primary-endpoint-head-head-trial/


 
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