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| Alias Born | 01/22/2014 |
Thursday, July 31, 2014 11:33:12 AM
As far as I can tell, the FDA is obliged to provide a response within 30 days, just as rverboatgambler mentioned while referencing this post (contains quotes and links from the FDA website if you're interested).
We know based on the previous HemaXellerate-related PR that Regen submitted the "clarification" on May 9th, which means they have definitely heard back from the FDA about this on or before June 9th, 2014.
If they received FDA approval from the May 9th submission, IMO we should hear about it in August with the Q3 (April 1 - June 30, 2014) report.
If they did not receive FDA approval from the May 9th submission and the FDA required more final information/clarification/etc., then it's likely that we could be within yet another 30-day FDA response window right now, or that we were earlier in July. The outcome of this theoretical "second FDA window" may not be communicated to us until as late as mid-October with Q4/year end reporting. However, it doesn't negate the fact that "soon" (definition: mid-August at the latest) we should find out what happened with the May 9th submission.
BOTTOM LINE: IMO we'll have an update by mid-August, which will allow for further educated guesses about the remainder of events (namely the potential for a Regen IPO).
Cheers!
$$ BMSN
Regen $$
We know based on the previous HemaXellerate-related PR that Regen submitted the "clarification" on May 9th, which means they have definitely heard back from the FDA about this on or before June 9th, 2014.
If they received FDA approval from the May 9th submission, IMO we should hear about it in August with the Q3 (April 1 - June 30, 2014) report.
If they did not receive FDA approval from the May 9th submission and the FDA required more final information/clarification/etc., then it's likely that we could be within yet another 30-day FDA response window right now, or that we were earlier in July. The outcome of this theoretical "second FDA window" may not be communicated to us until as late as mid-October with Q4/year end reporting. However, it doesn't negate the fact that "soon" (definition: mid-August at the latest) we should find out what happened with the May 9th submission.
BOTTOM LINE: IMO we'll have an update by mid-August, which will allow for further educated guesses about the remainder of events (namely the potential for a Regen IPO).
Cheers!
$$ BMSN
Regen $$ 
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