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baytdr

12/07/17 12:55 PM

#206720 RE: PlentyParanoid #206705

we know the DSMB did not conclude the data was futile.
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Yooper61

12/07/17 2:19 PM

#206741 RE: PlentyParanoid #206705

The placebo rate in Otezla’s Esteem 1&2 runs around 5.5%. Leo has been getting blinded case reports on all trial participants. To the extent the overall PASI 75 rate exceeds 5.5%, Leo would have an idea of P’s efficacy.

After 70% enrolled, Leo expanded trial sites. In the August 28th PR, Dr. B mentions the need for “a safe, EARLY, and sustained control of this...disease.” Why mention “early” if that wasn’t something they were seeing? The PR closes with “likely command significant market value”. If they weren’t seeing a PASI 75 significantly higher than the 5.5% placebo, I don’t believe they would have expand and PR’d as they have.