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Re: staccani post# 492

Sunday, 10/06/2019 9:09:14 AM

Sunday, October 06, 2019 9:09:14 AM

Post# of 8922
$CAPR thats exactly what I was thinking..They wouldn't host a conference call to discuss "expanded results" from interim analysis unless they had something more exciting to share...My guess or rather hope is:

Because they achieved statistically significant results in PUL 2.0 scores and also meaningful changes in cardiac and pulmonary functions (which were both endpoints defined by FDA for success) even with such a small subset and because this is a severe unmet clinical need FDA would be positively considering using HOPE 2 as registration trial and grant them accelerated approval..whether that FDA "end of phase 2" meeting they announced recently has already taken place or about to occur is the big question but I am sure they must have some updates based on ongoing discussions with them and also KOL's

Tomorrow they might announce results of CAP1002 in the HOPE 2 trial in patients at 9 and 12 month time interval and if they have achieved any statistically significant results at 12 month interval even in a small subset of their subjects then the chances that we hear FDA has granted/is on track of granting them accelerated approval by using P2 HOPE2 trial as a registration trial are very high and if we hear any of those things there is no need to say what that will do to the stock price with such a small float..
Good Luck to all of us for tomorrow!
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