R&P- Well, yes they very well could release that data then, if it's available. Who knows at the current rate? If the study isn't finished by then it would be another good sign which will be interpreted by the market as negative.
As impatient as I am to see data, I must remind myself that waiting longer is better, especially for the patients. If the data is exceptional, they could file NDA. Data will be also be trickling in from the GBM AGILE trial to influence the FDA. Considering the Biogen drug approval today which Gofish1 mentioned and the pressing need for brain cancer drugs as well as alzheimer's drugs, I'd guess there's more than a zero chance of Pax approval before the end of the AGILE trial.
From a MarketWatch article: "As the FDA described, accelerated approval can be based on the drug’s effect on a surrogate endpoint that is reasonably likely to predict a clinical benefit to patients, with “a required post-approval trial” to verify the drug provides that expected clinical benefit.Bernstein analyst Aaron Gal said approval under accelerated pathway is a distinction without a difference. “The pathway allows for approval based on surrogate market, rather than completed efficacy endpoint data,” Gal wrote in a note to clients..
PBnewby- Someone else mentioned chainsaws and new chains over on ST today. I'm taking that as a good omen.
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