If this trial is about safety and tolerability will the FDA take into consideration previous trials that have shown it to be safe?
If it is on purely safety and tolerability I would imagine that the market would have priced positive results in already, if that is the case all that's left to see is how positive the results are. The problem with the last results in Rett is that it was more a high level overview, the market can't really determine how effective the drug is off a few line graphs. Again if this is the case Monday could be a bit of a fizzler.
Also further along the NEU timeline with other indications will they take current trial results into consideration to reduce time for approval?
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