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Re: DragonBear post# 75676

Saturday, 09/30/2017 12:22:24 AM

Saturday, September 30, 2017 12:22:24 AM

Post# of 144814
Thanks, I'll clean up my notes and repost.

$PMCB's IP currently will be covered for 7 years via Orphan Drug Designation:

https://www.accessdata.fda.gov/scripts/opdlisting/oopd/detailedIndex.cfm?cfgridkey=457014

7 years with the clock starting on approval of course.

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

The original Austrianova patent did expire. The original process for CiaB being to manufacture encapsulated cells and immediately inject them. Since it wouldn't be possible to produce a master cell bank I don't think anyone else would consider pursuing that path.

The new technique is to make the encapsulated cells and to freeze them. Applications are pending for that process at Austrianova. I don't see how a MCB or WCB could be developed by any competitor without freezing.

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

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


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