Some of you will know that I was having a bit of an argument with On-Ice , oops, On-Fire I mean, last night. Yes, that was a waste of brain matter for me. But, you'll have that.
I am reluctant to specify some things that I know to be fact and standard practice for no other reason but common sense lacks with many over there and it takes only one to create a trickle effect. It happens every day and I do not want to be part of that.
That said, I posted an IND Approval For Dummies message last night (see link below). I encourage anyone who may be scratching their heads about the so-called "delay", "30 day wait period" & "clinical hold" to read it. Regen do not qualify for Categorical Exclusion or any Investigational Exemption OR Clinical Hold. Even some BP and research centers who have conducted hundreds or thousands of trials, receive responses from the FDA during some application submissions. Means nothing in the grand scheme; a request for clarification or additional info is standard operating procedure.
The Q&A could be about anything or anyone involved. It may have stopped with the June return. It may not have. We could get a PR today that confirms trials are scheduled for scheduling. We may not. It all depends on how the Q&A is being handled by the individual assigned the case. If thirty days lapses since FDA receives the responses (FedEx'd overnight) and no follow-up by the FDA is received within 30 days, then they have satisfied all of the FDA's questions and can proceed (and THIS IS WHEN THEY HAVE 4 DAYS to release the PR. Until then, further exchanges are immaterial and not subjected to disclosure law since Koos has already indicated the possibility of more Q&A. That is the disclosure law). However, if the FDA reviews the answer(s) given and such creates another question or need for clarification then they will respond to the questions with the required answer (can take a day or a month to send. Depends on who is handling the case).
That is how it goes. As complicated and frustrating as it is, still, it is all quite simple in terms of understanding the basics of how this process works. Q&A is not necessarily any reflection on Regen and their submission whatsoever.
Remember, they are new kids on the block to this so-to-speak. And though there are basic guidelines and questions that must be answered when submitting to the FDA, the more you do it, the more you learn--the more you understand HOW to say WHAT you say.
Have a great day all & Go BMSN.
IND for Dummies: http://www.kumc.edu/Documents/ri/cra/IND_101.pdf
