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efood125

01/10/20 9:19 AM

#112433 RE: vanderpol #112432

I am with you on that...it could very well be submitted already and waggs may have the CC when FDA approves it....wouldn't that be something if he did that on a Friday!
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fraum

01/10/20 9:29 AM

#112436 RE: vanderpol #112432

WRONG! PMCB doesn't even have the COA for the cells so its impossible the IND has been submitted.

Separate note isn't it funny how Pharmacyte and SMMG never release a PR in the same week? Seems like they coordinate their pumps.
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DragonBear

01/10/20 9:42 AM

#112440 RE: vanderpol #112432

Still think Waggs will/has not announce(d) submission...
I personally think its in


That's possible. With the last PR pump of 4 days ago being a charade.

I don't expect Kenny to ever announce the mythical IND submission, whether it goes in or not. Neither is it expected that Kenny will commit to doing so. Along with giving the final specifics of the mythical CT protocol to SHs.

All of this means, SHs get to guess. Speculate whether it has gone in or not. Speculate whether or not the FDA accepted it. Without knowing if or when the 30 day FDA clock has started, only speculation will be left.

Also, since the biotech industry doesn't announce when they submit INDs, but rather only when CTs start, PMCB has justification for not filing an 8K upon an IND filing. The industry doesn't consider the first IND filing as a material event. I've seen some give CC updates for late stage Phase 2, or before entering Phase 3. Thus, neither would its rejection be considered a material event for PMCB. Kenny could sit on a rejection for weeks. Gives him more time to issue PR pumps for a recovery from such an event. Yet another reason(s) he is extremely unlikely to announce any submission.