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Re: Going Coastal post# 41413

Monday, 10/05/2015 12:50:56 PM

Monday, October 05, 2015 12:50:56 PM

Post# of 144812
Ok, Ya sure there is a possibility for extension but FDA needs to grant it. FDA doesn't just grant extensions on forward statements made by a ceo regardless if he's an attorney. Below are some ways to gain an extension, unfortunately CIAB is unapproved so most are out of the question. Besides If LICENSEE (PharmaCyte Biotech) does not enter into a research program with the technology in the scope of the License involving European academic university partners, providing a total funding equal to or greater than Four Hundred Thousand Dollars US (US $400,000.00) within In three (3) years of the Effective Date. Which is up June 25th, 2016. They loose CIAB anyways so it won't matter.


-New formulations

-New routes of administration for known drugs

-Stereoselectivity/chiral switches

-Potential advantages of single enantiomer products

-New Uses

-Combinations

-Polymorphism

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3146086/?report=classic


As far as ODD, The post I originally applied to said this>

Quote:
"What is good at PMCB
Heading into the 4th Quarter with clinical trials looming, top world renowned oncologists, FDA Orphan Drug Designation and 7 years marketing exclusivity, EMA Orphan Drug Designation and 10 years marketing expected, New Trial Design expected soon, IND to be filed soon and cGMP facility ready to go soon.....life is good."

It didn't say 7 years upon approval or soon or anything in that regard. No it was stated as though pmcb had already achieved it. You and I and whoever else may know better but to the unsuspecting it's clearly misleading. It's no different than if the words "expected" and "soon" were left out in the other statement.

Or would that have been self explanatory to those researching pmcb too?

It's like someone once said, the mincing of the wording in pmcb throws up a lot of RED FLAGS...
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