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Sunday, 10/11/2020 12:55:47 PM

Sunday, October 11, 2020 12:55:47 PM

Post# of 144814
Why would anyone believe SH will EVER find out what FDA said or why they rejected???

To believe PMCB or Ken Waggoner will disclose any of the REAL information as to why the IND was on HOLD would ignore 20 YEARS of EVIDENCE of this company side stepping and not giving any information SHs deserve. EXHIBIT 1: COVID 19 TEST KITS. ( been months and not a word to SHs)

EXHIBIT 2. IND APPLICATION was given an extremely rare hold at initial application in the year 2020 win every company has the ability to ask FDA as many questions as they need to ensure the IND application is successful in at least allowing the trial to begin. It is even more rare that an initial application would be held when given an orphan drug status (easy to achieve by the way in LAPC given its lethal diagnosis) which means that PMCB is either incompetent or the treatment will not progress the current gold standards in place in this year not 1997.

We can all hypothesize about why the FDA has HELD this but one thing is for sure: KENNY WILL NOT BE TELLING YOU ANYTHING OF SUBSTANCE WITHOUT 100 DISCLOSURES ATTACHED AND MONTHS PAST THE DATE some are expecting.

1. They won’t even tell SH the DATE IND WAS HELD hmmmmm? Was it 3 days in or 30?

2. FDA CLINICAL HOLDS ARE extremely rare in this day and especially at initial application phase .

3. FDA DOESNT REJECT INDs unless a technical error has occurred with the application itself. They place HOLDS when their is a deficiency either in treatment or success or lack of required previous studies.
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