Feuerstein has one good argument in his article, that PVCT had said it was ready to go ahead with its phase 3 trial in November 2010 and had said that the FDA was on board. Then more than 3 years passed without any more formal trials.
I believe PVCT was waiting for protection through patents, and that getting its October 2013 patent was the trigger to move toward approval. But I can't prove AF's explanation (that PVCT was afraid to do more trials) is wrong.
But I feel certain that the FDA will not refuse to approve a phase 3 trial for PV-10 because it thinks other unapproved drugs, drugs with only phase 2 trial data (!) might turn out to be better, as AF claims:
"Given the huge advances in melanoma care today, FDA might be telling Provectus that it cannot proceed with the phase III study, as planned." This is ridiculous. The criteria are safety and efficacy, not comparison with other unapproved drugs, such as Nivolumab and Lamprolizumab.
In addition, his comparison of PV-10 with Allovectin's much, much weaker data is ridiculous as vandycommodores has shown.
I also think is nonsense for AF to say that PVCT will not be able to find patients because all the patients out there are already signed up.
Additionaly, his idea that their Phase 3 trial probably can't be conducted, because patients will be seeking the plethora of other melanoma drugs, is pure guesswork. One drug he cited, Bristol-Myers-Squibb's Yervoy, costs $120,000 in total for the treatment. While on the topic of Yeervoy, Feuerstein had no problem attacking Provectus's lead investigator of the Phase 2 Trials for PV-10. However, that same person was a co-investigator for the Yervoy trial.
Thursday, January 23, 2014
I have really learned from and appreciated your posts, especially the ones on competitor drugs. I had a lot of the information on Yervoy and nivolumab and lambrolizumab from my due diligence, but you had a lot more! The info on Agarwala as an investigator for Yervoy was very welcome. AF must know this. I think his whole article was written in bad faith as was his Monday tweeting, as the blog CTD hints. Your calling his idea that no patients would be available for PVCT trials "guesswork" seems kind to me. I would call it "far-fetched." But we will find out before too long. Thanks for all the good info. Diodia
I am not sure about the patents... did they get the patents then? you think that might explain a more than 3 year delay? not sure, but it's really a long time for being so inactive. I wonder if the management really was paying itself the huge salaries all this time...
What I was saying is that the 3 years of inaction was Feuerstein's one good argument. I specifically said I could not be sure that the problem was the patents. I am not a biochemist. But look at how the trading of PVCT changed after October 24, 2013. It is suggestive. Why would PVCT spend $20 to $50 million to prove a drug works just so that any other firm could profit from selling it? Even Feuerstein alludes obliquely to the patent problem for PVCT of using a 130 year old off-patent drug (Rose Bengal).
My point is that the "obselescence" argument is nonsense (and AF knows it), the "no patients available for PVCT" argument is ridiculous, and the comparison with Allovectin has no basis at all. All the rest of the article is just "OTC", "speculative," and other insults. Diodia