PharmaCyte Biotech Inc (PMCB)

[DragonBear]

Thanks, I'll clean up my notes and repost.-need_more_soap

7 years with the clock starting on approval of course.

Orphan drug exclusivity is granted to the first sponsor to receive marketing approval for the drug. What prevents a competitor from staging their own CIAB trials, getting FDA market approval, and getting orphan drug exclusivity? Nothing. But don't worry, it's doubtful anyone is interested in the equivalent of Ifosfamide Metronomic chemo for Pancreatic cancer. Pancreatic cancer will be treated with targeted Ab, or immuno therapy in combination with modern chemo drugs. Not by Metronomic Ifosfamide or an alkylating drug dating back to the 1980s.

Additionally, since it's a biologic, it would be granted market exclusivity for 12 years, again, on approval.

No. CIAB contains no new chemical entity.

Since it wouldn't be possible to produce a master cell bank I don't think anyone else would consider pursuing that path.

There's nothing impossible about it. It's mostly a GMP issue. Nothing to prevent "anyone else" from "pursuing that path", except no one else is interested.

The new technique is to make the encapsulated cells and to freeze them.

Wrong. Of the 3 patents you gave, 2 were associated with protecting freeze dried bacteria as in a probiotic, from stomach acid. The patent for the polyanionic encapsulating material spends quite a bit of discussion of disassociating the polymembrane, or releasing the cells inside for "downstream processing" (e.g. safely transport probiotic bacteria through the stomach, for release into the small intestine). It's eyeing different uses such as slow release drug therapy, or even something snazzy like stem cell delivery. Ref the patent.

Finally, PMCB has filed a provisional placeholder for the entire pancreatic cancer treatment process.

Which conveniently can not be tracked, until the 12 month post filing period is up. You can't just keep re-filing new patents to replace old patents expired. PMCB would have to file some new way to manufacturer CIAB. Or some new enhancement to CIAB. Else the USPO will reject it. What did Kenny tell the SHs about the new filing? Answer: Nothing.

Yes, 20 year patent protection would be nicer. But PMCB owns the Orphan drug designation and that's good enough for me.

Which isn't worth squat, unless: IND --> clinical trial(s) --> NDA. But first there's the GMP for manufacturing, and having a stable cell line to place inside CIAB. So how many years has Kenny claimed the front end issues had already been taken care of in PRs? Or at least being feverishly worked on? The sequence for this scam has been: Hype about manufacturing&cell lines, then came pre-IND hype, and now it's back to manufacturing&cell lines. That ought to be good for many more months of PR hype. Periodic pivots in diabetes, and THC to create pumps he can dump into will follow. Where's that IND?