Spectrum Pharmaceutecals Inc (SPPI)

[antihama]

Major PR could come out this week on posi news. Previously calculated that they had their pozi pre NDA meeting by Nov 17th

We know they requested a pozi cohort 2 pre-NDA meeting on either the 16th or 17th of September. Note on Sept 16th, at the Cantor CC, they were still saying they will schedule a meeting but on the 17th their ESMO PR stated they requested a meeting. The FDA has to schedule a Type 2 meeting within 60 days of the request so, at the latest, the meeting will have taken place by Nov 17th.

And the Agency is obligated to provide written meeting minutes within 30 days which brings us to Dec 17th. Did they need to wait to getting the meeting minutes to issue a PR? No, since they know the FDAs thoughts by participating in the meeting but 1) it's safer since the FDAs thoughts are in writing and 2) they may be waiting to issue a combo PR along w pozi Z20 cohort 3 TLD especially if some of the news is negative. My thinking is if any news will be negative it will be regarding cohort 3 w the once a day 16 mg dosing. Who knows, maybe we'll get 2 PRs...and they're both positive :).