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Saturday, April 27, 2019 8:00:19 AM
Not worried about PMCB timing as long as final documentation helps to prove the science behind their novel platform and achieves the best product as possible for IND process and humanity!!! Ladies and Gentlemen this will happen soon.
Check out this article:Preparing for Your First IND Submission: The Devil is in the Details When preparing an IND submission, an open mind and ability to
Jan 01, 2008 By Conrad J. Heilman, Jr., PhD, Joseph J. Villafranca, PhD BioPharm International Volume 21, Issue 1
Here is the link http://www.biopharminternational.com/preparing-your-first-ind-submission-devil-details?id=&pageID=1&sk=&date=
"In fact, the best way to get the most out of the IND submission process is to see it as a way of helping you produce the best product you possibly can."
"DOCUMENT AS YOU GO
Some first-time applicants wait until very late in the process to begin creating the IND application. You should write up each of the milestones required on the application as you complete them, instead of being forced belatedly to put together what is usually a voluminous document. The documentation will be fresh and you will have time to make sure that it is scientifically sound, addresses a medical need, and has a safety profile appropriate for the clinical indication. If your organization does not have prior experience with writing INDs, hire a professional contractor who understands the types of issues that the FDA often raises. This will be money well spent, because your IND document will be professionally prepared according to FDA expectations."
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