- Provectus Biopharma (PVCT) fights back against Adam Feuerstein's negative article yesterday, claiming the article contains "several inaccuracies and omissions" and the "cherry picking of negative data" appears intent on implying that its long-delayed PV-10 melanoma drug is destined for failure.
- In a separate release, PVCT said PV-10's path to initial U.S. approval is "now clear" per FDA meeting minutes, with Phase 2 data to be submitted in a formal BTD request this quarter with an FDA response expected within 60 days of receipt.
- Feuerstein responds, saying investors should consider the BTD filing a "Hail Mary," noting that "BTD does not equal drug approval. Nowhere in today's update does Provectus confirm that FDA will allow an approval filing or actual review for approval PV-10 based on a tiny phase II study, even if BTD is granted. BTD in the absence of well-designed clinical trials demonstrating clear efficacy and safety doesn't mean much."
- Shares gained 14% today, but it's hardly enough to make up for yesterday's 64% crash.
Provectus says PV-10's path to initial approval is "clear," Feuerstein differs
Jan 24 2014, 17:43 ET