Is it possible that as the clinical (trials) learning process has gone forward and the (DNA/GUT/other) data from serialized pts produced certain key new information (importance was unknown when they began)?
Then, they all agreed that the new knowledge was critical and must be understood. That stopped the trial planning? Like all processes when discovery is happening they would have had to convert the new information into something meaningful and relevant for evaluation. The new FDA trials guidance will reflect this new knowledge. IMO.
Meanwhile, with a room full of smart people (some regulatory w/influence) a dynamic is expected where new knowledge is tested/argued. Fill in the blanks for yourself.
Of course something like that has occurred wA2-73 AD results and that process will repeat itself for the next few years. There will be (maybe already has) a Breakthrough. Follow on BT won't take so long as the results become more certain and predictable. I think that is what the FDA-ACTC is supposed to help with but it has not been there the past 30 years. Of course the process was slowed/held while they figured out what to do. It would have been nice to have anticipated that before the, " 3 trials" , announcement. I am optimistic we have a BTD, if A2-73 was a dud they would have stopped looking. The delay sucks but it is actually a good sign, IMO.
Good news is (IMO) the new outcome is more predicable, approaching certainty. Eventually we will see effective AD treatments. While, in the meantime, I expect RETT, PD and other indications to move quicker but essentially on the same kind of learning curve. The trial and error days are gone.
I would expect at some point soon (If this all works out) that AVXL is platinum rated investment as smart people get on board. BP is in deep shat. The new trials processes will also make it clear why the past 30 years or so of enormous expense and painfully weak BP processes failed so badly.
