Hi, Gary. Good to see you're hanging in there, and sorry about what's happened here. I'm not sure what the FDA might be willing to do with this data, as even the favored subset failed the primary. Since the unmet need remains high, they might be more accommodating than normal under such circumstances, particularly if the FDA had been mean about the design. I would guess there'd be an AdComm, and a dicey one at that. In hindsight, even if the FDA forced them to accept less favorable populations, they needed more power than they had with this analytical plan (i.e. more patients, meaning more time, and more money). The FDA may even have suggested more power, and the company may have declined. We'll probably never know that.
But I can tell you that pseudoprogression is generally rare in oncology (less than 10% across all tumor types) and the limited data to date suggest it's specifically even more rare in ovarian cancer.
Pseudoprogression and Immune-Related Response in Solid Tumors
So I wouldn't hang your hat on that concept.
Other companies have also had late stage failures with this target. Some are questioning the target. Then there was the insider selling shortly before the release . . .
For the record, I went short some March $3 calls for a trade after the data release, simply because I don't think anything of import will happen before next Friday, and the implied volatility was too high not to harvest. After that, I will stand aside and watch. Hopefully, the company can pull a rabbit out of its hat.
Good Luck, and Cheers, Tuck |
