PV-10 Immune Mechanism Data to Be Presented at the American Association for Cancer Research Annual MeetingBusiness Wire (Thu, 11:58AM)
Business Wire (Jan 24, 2014)
Business Wire (Dec 18, 2013)
Provectus Announces Name Change to Provectus Biopharmaceuticals, Inc. and Reincorporates in DelawareBusiness Wire (Dec 17, 2013)
Provectus Biopharmaceuticals specializes in developing oncology and dermatology therapies. Its novel oncology drug PV-10 is designed to selectively target and destroy cancer cells without harming surrounding healthy tissue, significantly reducing potential for systemic side effects. Its oncology... More
Friday, Jan 245:43 PM
Friday, Jan 245:43 PM| 23 Comments
- 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.
Thursday, Jan 2312:02 PM
Thursday, Jan 2312:02 PM| 39 Comments
- Speculative manias tied to Bulletin Board cancer drug stocks usually end badly, and TheStreet's Adam Feuerstein thinks there is nothing to suggest the mania surrounding Provectus Pharmaceuticals (PVCT -6.5%) will be any different.
- PVCT shares have soared from $0.80 in December to $6.03 earlier today, doubling in price in the past seven days, amid rumors that FDA officials may sanction an accelerated approval filing of PVCT's long-delayed skin cancer drug PV-10.
- While shares surge on speculation that the FDA wants to be more lenient with PV-10's approval pathway, "the more sensible explanation is exactly the opposite... Given the huge advances in melanoma care today, FDA might be telling Provectus that it cannot proceed with the phase III study, as planned," Feuerstein writes.
Instablogs are blogs which are instantly set up and networked within the Seeking Alpha community. Instablog posts are not selected, edited or screened by Seeking Alpha editors, in contrast to contributors' articles.