Thursday, January 31, 2013 4:39:49 PM
IMO, and based on conversations I have had, I believe:
1. The FDA is very sympathetic to PPHM’s situation and will schedule the EOP2 meeting within 30-60 days of receiving the reconstructed NSCLC data, which they will receive about the same time we see it in the pending PR.
2. The FDA will approve Bavi to go forward with a large Phase III trial that includes an interim look at some smaller subset of patients. AA may not be entirely off the table, but at least PPHM will get the chance to cut the trial short if results from first 100 or 150 patients are outstanding (like the Phase III Cotara protocol).
3. As SK said in the Q&A at end of the last CC, interested BP partners will make their move to finalize terms of a Bavi license after the FDA finalizes terms of the Phase III protocol. IMO, the FDA discussions will move quickly (because FDA is sympathetic) and could easily conclude by mid April, with a BP partnership concluded around mid-May.
4. ASCO will be a big event for PPHM this year, with presentations of 2nd-line NSCLC, front-line NSCLC, pancreatic and IST data.
5. One or more Cotara regional licenses will indeed close before summer.
All IMHO.
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