I think there will be an open label extension at the end of the upcoming confirmatory trial and I think that will give the company the opportunity to monitor patients and provide for the second cycle of bryostatin treatments that Alkon mentioned last month that could possibly provide for even additional synapse growth and SIB improvement while still allowing for a quicker confirmation with the 15 week data endpoint. That's my hope anyway.
I really don't know how much we will need to do to get the FDA to allow severe Alz patients true access to this drug but I don't think its going to be a long, thousand plus patient trial that takes several years. That's why I'm hoping for the fast tracking and for Alkon to know exactly what he needs to show the FDA to approve this drug for this population, especially with the new guidelines and streamlining in the FDA. We'll all guessing at this point. When we see the guidelines of the upcoming trial, we'll have a better idea. I'm curious as to how many patients the FDA will want to see in this next trial. We have a HUGE advantage here with our safety profile and if we can prove a viable option to reverse this disease with the confirmatory trial, we are going to be much closer than some imagine IMO. Simply treating symptoms would be one thing but reversing the disease would be the path the FDA would have to sign off on. JMHO
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