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pphmtoolong

11/24/13 11:55 AM

#150024 RE: biopharm #150000

Biopharm, I'm all for early approval of Bavi. However, there's always a however, this idea that a look at blood samples taken during the Phase III Bavi NSCLC trial will result in early approval sounds iffy at best.

From my point of view, a solid partnership or buyout does not depend on this iffy route. More data is coming from the ongoing ISTs as well as the preclinical work on Bavi with the rest of the immunotherapies. Not to mention, if ABBVIE was close to pulling the trigger on a deal Steve King wanted (remember the story of his last minute attempt to save the deal after the Fargo fiasco) based on the Phase II study, how much readier might potential partners be now.

I am fairly confident that Peregrine-Bavi are partnerable or buyable in the next few months without recourse to some unorthodox approach to early approval of Bavi.

GLTA, Paul

biopharm

05/14/14 1:39 AM

#176303 RE: biopharm #150000

Accelerated Approval I say is likely - start at line 525 page 20

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM358301.pdf

.... and all the pre-clinical collaborations that are going on with companies such as Ambit just may bring some BTD's Peregrines way, since BTD's can be based solely on pre-clinical data. Its been at about 5 months now that Peregrine has been in collaborations with Ambit so data could be coming any day.