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Re: None

Thursday, 11/09/2017 9:34:57 AM

Thursday, November 09, 2017 9:34:57 AM

Post# of 144836
Shareholders who acted on the inside tip given by the rouge poster on PMCB's Facebook page were given a gift. IMO the recent shareholder call was a ruse to cover up a fatal flaw in the steps taken by PMCB over the past 15 years leading up to the IND for CIAB. As identified by the deleted internal post, the previously released human safety results were done over a decade ago, the data past its effective date, is therefore obsolete, and specifically did not enroll enough patients to compile enough credible data to make a reasonable determination that the enzymes being encapsulated will not biologically alter in vitro. In fact, the patient population in the early safety trial was 14, not near enough of a representative population for the FDA. This means the whole clinical trial process must be started over from the beginning. Unfortunately, if PMCB does not run out of cash and makes it to the IND, that is when you will find out you have to go back to start.

Don't take my word for it ... Read for yourself ...

Here are the FDA guidelines ...

https://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm073459.pdf
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