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reg2015

01/16/19 4:19 PM

#208664 RE: sentiment_stocks #208621

Please make this post a "sticky" and someone start to compile the questions to be submitted before the meeting. JMHO, This entire post should be submitted, as is, to Les and he should tell us he got it and will answer the questions on it in one form or another and tell us why he answered the way he did so we are clear about what he can and can't say and why. Peace Reg 2015

notbrad

01/16/19 6:01 PM

#208683 RE: sentiment_stocks #208621

1. Was there ever an unblinded efficacy IA done, and if there was, does management have any knowledge about the statistical comparison - or the extent of separation - between the control and treatment arms?



Senti, why is this question necessary at this stage of the game? Will LP really answer it? Do we want her to tell us that "yes, there was an interim analysis and we saw no separation". I don't know what happened and, at this point, I don't want to know. Any potential answer is just fodder for the wolfpack.

hankmanhub

01/17/19 10:09 AM

#208770 RE: sentiment_stocks #208621

I would want answers to the following questions in order of priority:

How long (in months) to scrub (if not already begun), to lock, to top line, to release of stat anal, to FDA filing (if results are positive)?

Are you re-analysing the psue-progressions and when will that be completely done?

Have you considered whether Cognate is still a reliable supplier and are you satisfied that the answer is still YES?

When do you expect P2 for direct to start?

When do you expect the combo trials to start?

When will the Black report be ready for release?

Please explain the reason for the hold or why you can not tell us?

Do you expect the US or UK approval track to move more quickly to approval?

Have you turned down any actual partnering deals with BP?

Have you turned down any actual but outs from BP?