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Re: kld2 post# 2219

Tuesday, 03/21/2017 6:49:14 AM

Tuesday, March 21, 2017 6:49:14 AM

Post# of 21531
They needed to get an approval from FDA for the protocol.

Phase 2a was the first trial where Bryostatin-1 was given to Alzheimer's patients. So they needed to see there was target engagement (according to MOA hypothesis) and preliminary rudimentary safety in this population before proceeding to the next phase.

I would see this as an issue if the company would seem to delay the development (in order to collect as much money as possible). But as you probably agree they have actually been very efficient in their execution and are already about to get some definite data from phase 2b. It's not that usual thing in this space IMO and tells how anxious they (and FDA) are to see whether or not this mechanism works.

BTW. They saw some modest effect at least in some of the patients in the phase 2a. But it was too small to count that much (no statistical significance) so they didn't report it at that time. I think CEO or Dr Alkon recently told it in one of the presentations.
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