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Re: misiu143 post# 15646

Wednesday, 06/28/2017 8:58:04 AM

Wednesday, June 28, 2017 8:58:04 AM

Post# of 232949
Even if mono gets enrolled by the end of the third quarter, you still have almost a year for the trial to be completed, then it takes quite a bit of time for a company to compile the trial results and put together the FDA application. Then the FDA will take at least six months (the practical bare minimum) to produce their decision on mono. For Theratechnologies, which had only a 40 person phase III trial for Ibalizumab, which has the BTD, it took them six months from the end of the trial until when they submitted their application to the FDA. So you have a year from the last patient enrolled just to complete the trial and likely a year for the application to be assembled and for the FDA to review it. You might pick up some time because it is a second indication (following the hoped for earlier combo approval) and because PRO 140 might receive the BTD too, but that is already reflected in the optimistic info I stated above. It is more typical for these things to be delayed than to move faster than expected. Even after approval, it takes a little time to get labels printed and get the drug on the market. CYDY will be relying on a partner for marketing and timing will not be in their control. History suggests that there are a lot of ways new drugs get held up longer than any investor feels is reasonable as they make their way to the market.

So, you better be counting on late 2019 for Mono commercialization. Anything earlier than that would be a fortuitous break.

I see other posters are counting on a buyout before that anyway. If the drug is as good as we think, then the last thing you want is a buyout as that will mean current investors will be transferring meaningful value to the buyer that they could have had themselves. This could be a huge drug and there is no way you want it to fall into someone else's hands.
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