Spectrum Pharmaceutecals Inc (SPPI)

[antihama]

Pre-NDA Meeting with the FDA has been scheduled! We know that from today's ESMO PR

Cohort 2 was designed to be a registrational study. Based on these results, Spectrum has requested a meeting with the U.S. Food and Drug Administration (FDA) to discuss the data and its plans for a New Drug Application (NDA) submission.

Assuming it was requested today, they'll meet within 60 days which brings us to Nov 17th.The FDA will then have 30 days to issue the meeting minutes which brings us to Dec 17th. So maybe we'll have a nice present under the tree instead of coal like we did last Christmas.

The Sept Corporate Presentation said pre- NDA meeting by EOY which soured my mood a little and I thought that's what they said yesterday's at the Cantor Global Healthcare Conference but I have to go back and confirm they said by EOY and not that it was scheduled which would move the timelines up. Will respond to this post if that's the case. Regardless, this new bit of info ie knowing the meeting is scheduled, does brighten my mood some. All systems go!

Here's the ESMO PR link
https://ih.advfn.com/stock-market/NASDAQ/spectrum-pharmaceuticals-SPPI/stock-news/83288806/spectrum-pharmaceuticals-presents-results-in-her2