regulatory processes (plural) .... way to go Mr Hess and my favorite part of the release this morning:
Said Brian Hess, InVivo Chief Technology Officer, “We appreciate the collaborative dialogue we have had with the FDA. Since our April 2012 meeting, we’ve established regulatory processes to treat neurotrauma with biomaterials, and we’ve completed knowledge transfer with the FDA that we believe will benefit all of our additional products in development.
again I will say that new first in line treatments to meet unserved medical needs will absolutely face these issues of clarification, compliance, processses etc to gain approval.... this is exciting to be so close!!!
A. We dont know when this new information was submitted B. We dont know when FDA will reply. The IDE and HUD are coming up soon we just need to be patient and let FDA absorb the new information. Communication is good.. we are moving closer to the finish line.
This is the ide... I think this is good news... I think the HUD app will be approved and the IDE response has to be within 30 days of submission I believe.... Trials may really be around the corner...To me this is very positive... But... who really knows... May be taking too many decongestants this a.m.
but if the original deadline was in January and the FDA delayed this---does this news refer to that delay-resubmission thus ~March 9--if not why wasn't this January resubmission not reported by In Vivo back in January---if this is a new submission is this now the second resubmission? (December submission--January delay----resubmission---~late February delay-another resubmission-----April decision or delay again??