PharmaCyte Biotech Inc (PMCB)

[Triple9]

What prevents a competitor from staging their own CIAB trials, getting FDA market approval, and getting orphan drug exclusivity?

The competitor's legal team. No one is going to pursue a CiaB type trial only to be sued for IP infringement.

No. CIAB contains no new chemical entity.

This is a biologic and it will be evaluated by CBER.

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.

PMCB has filed a provisional on the full CiaB pancreatic cancer treatment. That is not a refiling. The Austrianova patents that have lapsed were for the old encapsulation process. The latest Austrianova filing is for a new encapsulation process that can withstand stomach acid. Seems to me a smart IP law firm is using the fact that CiaB can now withstand stomach acids as the basis for a new patent. For sake of argument, assume the old CiaB process was a 20 step process and assume the new CiaB process is a 25 step process. This is done all the time to protect IP and they are literally called Improvement Patents.

Which isn't worth squat, unless: IND --> clinical trial(s) --> NDA

The market is placing a value on $PMCB of $50+ Million. Further, based on the new S-3, someone is considering a new $50 Million investment. That would be a rather epic vote of confidence.

Finally, I completely fail to see how a renown doctor such as Dr. Manuel Hidalgo would waste his valuable time with PMCB if everything were as gloomy and futile as you suggest.