Wisebuys is dangerously stupid. He has no business being a MOD either.
That is only APPLICABLE when there haven't been any questions or need for clarification of the application. THAT 30 DAYS NEVER CAME because the FDA had questions from the word git!
Let me try this again:
Regen submitted application. Upon receipt of that application, the FDA saw one or two things in the information provided that required clarification (i.e., lacked some pertinent contact details for those in charge of monitoring the trials, subjects with diabetes eligible to participate, Y or N, Koos really wears a DD bra...., etc., etc.). The FDA submits their request for clarification to Regen. Regen answers the questions and returns such to the FDA. If the FDA is satisfied with their answers, nothing else immediately should occur. If this is the case, trials will begin 30 days after the answers were sent to the fda.
IF the answers provided by Regen then creates more questions by the FDA (such as, OK, if diabetics are accepted, what types of effects (if any) might the treatment pose should during the course of the trials, the diabetic suffers kidney failure that is totally unrelated to the treatment? Regen then answers that question to the satisfaction of the FDA and they finally leave Regen the hell alone.
Approval is granted. Trials begin.
Now, during trials, the information that exchanges is ongoing. And, something might come up about the company that they did not disclose on the application. Or, something is brought to their attention by someone/something unrelated to the Regen and they feel that Regen has not properly disclosed all that is required or lied outright. THEN is a clinical hold issued.
The above, including Koos's bra size is merely hypothetical's. However, the explanation of how it works is not.
