Absolutely untrue. Porky, I am in your corner most of the time. But, this time you are very much incorrect. Please do not encourage such erroneous and inflammatory postings as you have with this response.
Let me be clear: A clinical hold is imposed typically AFTER the FDA has provided approval and an issue has surfaced post this approval (i.e, through further investigation they find the applicant submitted false or misleading info, human subjects will be at certain risks not indicated in the application, subjects are being used that should be automatically disqualified for other risk factors, etc., etc.,). The application process has not reached the status as of yet (that we know of) that would subject it to a clinical hold.
The current state of the application is the process whereby the FDA is seeking answers that may or may not have been clarified during the initial submission. Perhaps they are seeking more info on who will actually be conducting the trials. Perhaps Koos omitted a minor detail such as something with mandatory exclusions. Perhaps the application lacked a signature. WE DO NOT KNOW! But, I DO KNOW that there has been absolutely nothing to indicate there has been a clinical hold on their request to proceed with clinical trials. NOTHING! NOTHING! NOTHING! On the contrary as a matter of fact if you look at the studies in toto.
Please stop assuming the worst because the best has not been placed before you. There is nothing easy about dealing with the FDA. When was the last time anyone had their tax return considered without inputting your income? It doesn't happen. We are talking about conducting human trials and working through the FDA. It can be a nightmare at times and it does take time!
BMSN!
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