FDA approval for a drug that is just in phase 1 within 18 months?? How are you getting that? It's just 6 months minimum after getting a PDUFA date! And they wouldn't be ready to submit a NDA in a year! Also it's a bit early to be saying 534 works since they have only done a phase 1 trial! Might want to atleast wait until a larger phase 2 blinded study before proclaiming the drug works.
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