Replies to post #112646 on PharmaCyte Biotech Inc (PMCB)

[vanderpol]

PharmaCyte’s pancreatic cancer therapy was designated an orphan drug and listed in the official registry of medicinal products for rare diseases by the U.S. Food and Drug Administration (FDA) on December 17, 2014. Orphan drug exclusivity would provide marketing exclusivity for PharmaCyte’s pancreatic cancer therapy in the U.S. for 7 years after market approval by the FDA. Similarly, PharmaCyte has orphan drug status in the European Union (EU) for its pancreatic cancer therapy, which provides 10 years of marketing exclusivity in all countries in the EU following approval by the European Medicines Agency (EMA).

In addition, the Biologics Price Competition and Innovation Act (BPCIA), which was enacted as part of the Affordable Care Act in 2010, establishes a period of 12 years of “data exclusivity” for reference products to preserve incentives for future innovation. Under this framework, data exclusivity protects the data in the innovator’s regulatory application by prohibiting others, for a period of 12 years, from gaining FDA approval based in part on reliance on or reference to the innovator’s data in a biosimilar application. PharmaCyte’s 12-year exclusivity will begin as soon as the FDA approves the company’s first Cell-in-a-Box®-based therapy.

[DragonBear]

Patents rejected and Uncle Kenny hide from us again

He was probably too busy in Thailand watching cells grow to notice.

I stated early on, a drug company just can't take a patent that has expired, and then file for a new one. One has to make new claims which are not obvious. If PMCB were allowed to get away with such nonsense, the generics would be out of business. Every drug company with a major drug on the market, due to expire, would just submit a new patent.

Then there was the idea Kenny had made new claims. Apparently the USPO thought otherwise. They initially turned it down in Jun, gave an extension in Oct so Kenny could make a supplemental filing, and then rejected in for good in Nov.

Oh, but it's designated Orphan. However it's not approved. The good news for PMCB SHs is that no one in the biotech industry is interested in the Kenny Wonder Treatment. Else, they could have made their own magic cells last Jun, encased them, and been in CTs ahead of PMCB.

Another factor is this is not 2014. It's almost 6 yrs since PMCB got their orphan designation. There are treatments for 2nd line PC patients. More are on the way in CTs. Treatments the Kenny Wonder Treatment will not be able to match. Thus, the FDA won't be cutting PMCB must slack.

All of this dovetails into the dream some Pharma is going to buy PMCB at a PPS it will take the acquirer 150 yrs to recoup or recover from. What would they be acquiring? Answer: A pile of issued stock. A large Pharma didn't get to be large by making stoopid decisions.