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greens12

07/16/17 12:20 AM

#423 RE: ZeWaffleBaron #422

Thanks for another great honest analysis. Biotechs are risky but rewards can be huge. I sure hope we have a better than 30% chance , that does not sound good for Phase 2's. What are Phase 3 odds in Biotech industry with FDA ?

Something about the way they put the timelines for results together makes me think they know 1 of the trials might not be good...? I was thinking the opposite of you and that 5211 data was sketchy and they decided to back it up so the stock would not crash if results were to happen in June as first planned....Management does not seem to be very shareholder friendly with the way they jerk timelines around twice.They seem to be scared or hiding something by the way they are acting...trust is a factor here for me.
GLTA
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greens12

07/17/17 7:52 PM

#424 RE: ZeWaffleBaron #422

"Some 63 percent of drugs in Phase I testing advanced to Phase II, but only 33 percent of Phase II drugs made it to Phase III, which requires a commitment to larger and much more expensive clinical trials. Phase III is typically the final stage of human testing before a new drug is submitted to regulators for an approval decision.

Not surprisingly, the numbers increase after that as the drugs had already shown success in the clinic.

Approval applications were filed for 55 percent of the drugs that made it to Phase III testing, and 80 percent of those gained eventual approval, although only about half were approved on their initial FDA review.

The 80 percent approval rate, while seemingly high, is down from 93 percent seen in studies of earlier years."

http://www.reuters.com/article/us-pharmaceuticals-success-idUSTRE71D2U920110214