Just wondering, is it forbidden to ask if a provisional approval is possible?
The EMA is aware of the OLE but remember Janet Woodcock talking about the great need for SOMETHING, anything for people demanding a drug? What was that, 3 years ago? Still no drug, to speak of?
Anavex could put something in front of the EMA, then let them decide if it is enough. Why should Dr. M's overly conservative, You'll understand why we did it this way..., timeline hold back relief for millions?
Let those whose decision it is at least have the option to say, OK, go ahead but understand if the OLE is a disaster then some adjustments will have to be made. If the OLE is OK, not great, just OK, then full speed ahead.
It's all about safety and I really don't see the great risk with compassionate use folks on it for 4 years
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