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smallbio

05/29/19 11:42 AM

#264 RE: smallbio #263

Last sentence of:
"I do think the planned MDD phase 3 trial has a higher chance to succeed based on the P2 data as P2 is with comparator arm (Wellbutrin) vs P2 is with placebo. "

Should be like this:

I do think the planned MDD phase 3 trial has a higher chance to succeed based on the P2 data as P2 is against active (Wellbutrin) comparator arm vs P3 is against placebo.

Goodtime13

05/29/19 1:16 PM

#265 RE: smallbio #263

Per their language they are enrolling more patients in the trial. Importantly - it is because of an agreement they have made with the FDA - to acquire more data.

Axsome would certainly not add additional patients to the trial if they thought doing so would decrease the chances of a positive readout.

What is comforting is that buproprion and dextromethorphan are known commodities so in my opinion, surprises are unlikely. In addition, TRD patients are typically younger and thus, in theory, less compromised than other populations.

MDD is in the bag IMHO.