Jeffrey S. Weber, MD, PhD,
director of the Donald A. Adam Comprehensive
Melanoma Research Center
at Moffitt Cancer Center, Tampa,
FL, said, “Some distant metastases
could even regress after its use locally.
Such drugs have a potential use as
an immune priming prior to the use
of checkpoint protein inhibitors, and
should be evaluated in combination
with those drugs.”
I expect the Phase II trial protocol to be submitted to the FDA any day now. The start of enrollment would likely occur not long thereafter, as there is no need for Provectus to wait during the 30 to 45 FDA comment period that delayed the PV-10 Phase III melanoma trial.
I had a chance to talk with Dr. Dees yesterday and he was very accommodating as always. My takeaways are as follows
1. I asked him if the Chinese contract needed the melanoma protocols or the liver protocols finished prior to the contract being finalized. He said the contract would be signed once either one of the protocols were finished and approved by the FDA. Although he couldn’t give specifics, there is upfront money involved. He said they had an opportunity to sign a contract 4 years ago with the #4 largest pharmaceutical in China, but decided not to because the company wouldn’t put any upfront money into the agreement. He also indicated the India contract (maybe MOU?) could be finished prior to the Chinese contract. I was a little unsure what this meant so my take away is some type of agreement with India is close.
2. I asked him if the liver clinical trials would be finished prior to the melanoma clinical trials and he said this was possible. As mentioned before on this board the liver protocols are finished and PVCT is trying to prepare them for submission to the FDA. Also interestingly, I think he indicated they are planning or submitting the liver trial as a combined phase 2/3 liver trial.
3. In regards to the date of their meeting with the FDA, although the hope is for Jan/Feb, they are at the mercy of the FDA in regards to the meeting date. There is no guarantee that it will be in Jan/Feb although that is their hope.
4. I asked him about veterinary use of PV-10 and he said it has been successfully used in a limited way. Interestingly, he said once PVCT is approved for human use by the FDA, then it is automatically available for the veterinary market.
We didn’t have the best connection, so I hope I’m accurately reflecting the information he relayed to me
Thanks much for the email and question. I did deal with this topic in our Q3 conference call and 10-Q for Q3 (November 6th). This revenue generation hinges on regional license transactions and co-development partnerships. Both of those hinge on clinical development (as in phase 3 melanoma commencing, liver 1b/2, PH-10 MOA, combo 1b/2). Of course, these are all in process of being fully underway, so revenue generation is potentially near term.
We’ll update this topic further in planned conference call this quarter which we’ll announce publicly.
Thanks again, Pete
Come on dude give us your version on what happened with Dees and how he mistreated you.
That woks out to 1 post every 2 hours everyday of the year.... just saying
Yes please tell me of a company where 1 executive used all his take home pay over the last 10 years and invested back into the company..... Along with 2 executives that have purchased pvt placement stock along with Directors of the Board....Tell me of these company's that failed where mucho exercise was happening along with buying pvt placement stock.... Thanks...
"The development of new therapies to assist patients with refractory disease is of high importance to the FDA," Pazdur said in a statement. "Today's approval gives patients and healthcare professionals a new therapy to help slow the progression of [differentiated thyroid cancer]."
Hi Joe, not yet, since we will issue press release about; however, we said on last two calls that at minimum we’ll do conference call when we file SEC quarterly and annual reports. 10-K is next, which is in March. We also said that conference calls can be earlier based on significant news to communicate (which in our case would be very positive news we believe).
Please let me know of anything else.
"years of survival data".... someone said that.....why else insiders investing 7.5m back into the company.... via direct purchase and exercise... come on dude...