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F1ash

02/24/17 9:19 AM

#93073 RE: BAR123 #93070

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Why doesn't the P2a and P2b trials count as a complete P2 trial already?
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Because there is no P2b trial. There was a P2a and an extension of that trial. There has been no P2b that would be designed and powered to show efficacy.

https://clinicaltrials.gov/ct2/results?term=Anavex&Search=Search

I'm interested to hear comments on the combo 2/3 trial as well.
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wildcard235

02/24/17 10:13 AM

#93092 RE: BAR123 #93070

My understanding: There is no legal definition of phase 1, 2, or 3, and how the terms are used in the industry are a little soft, but the general concept is phase 1 clinical trials use healthy subjects to determine the safety of the drug candidate, phase 2 is a relatively small-scale test on subjects with the target indication (disease) to see if there is any sign of efficacy, and phase 3 is a large-scale trial to determine if efficacy is better than placebo. Phase 4 trials are performed after a drug is on the market, sometimes in lieu of phase 3.