I consider the following scenario at least possible for Monday, June 7th.
FDA releases findings on decision, probably mid day. They have decided that the BIIB trial results are incomplete (considering importance) and require additional trial(s) from BIIB. But, there is some kind of (Wink-Wink, Nudge-Nudge) positive spin from FDA. So, no it is not approved but standby for good stuff...inference.
So, the BIO market goes baeserk-up-down-sideways. Then AVXL publishes (early) PDD-trial data that looks very strong-positive, but nothing-co FDA comment. A strong bubbling noise can be heard from WS. MJF says something very positive in support of A2-73, declares support for AVXL efforts WW. RSD WW Organization schedules major conference to announce positive trial news, does not state the treatement...yet.
Lot of scenarios are possible. I cannot see Dr.M just letting such a long awaited set of critical news events go by w/o suitable AVXL actions and reactions, planned events to follow up.
My opinion is the FDA cannot approve BIIB trial drama results as adequate. No one knows what they will require next. A child can see the need for very strong science in AD trials if an approval is forthcoming, that science has not been demonstrated. If it were strong, we would have smelled it or seen such by now.
So, Monday is a big day for a lot of people. Hopefully, we never have to go through this again. OUR MOA is a killer, IMO.
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