RE: FDA grant of a De Novo request=authorized to be marketed21 Oct 2024 15:25
Rocking... 'Not sure why you or Roger are hoping it to happen in next couple of months'
I've repeatedly stated the earliest I think FDA approval could come for Mt-RNR1 via the De Novo route is EASTER or APRIL 2025. I am fully aware that the De Novo process for FDA approval hasn't even started yet due to data gathering. I'm the one who has been posting this info recently trying to correct another poster who seems convinced it began when the RNS on July 15th.
There is a limit of 180 days from I think July 15th during which GDR are allowed to consult with FAD in order to provide all the data and info they require. The process must actually be started within that 180 day limit or else GDR have to start all over again in registering their product. I had missed this. There is therefore some pressure on GDR to get their act together and ensure they don't miss the 180 day deadline. By my reckoning that's January 15th and this is exactly what GDR have said, they hope to get things underway by early 2025. The FDA decision can take 150 days but now with new Breakthrough device designation and FDA and a change in its own methods of reviewing such products, this can be reduced in some cases to as little as 90 days.
Anyway, all of that is for shortly after Christmas to worry about. Right now we need news on these NHSS assessments and to hear of more hospitals launching the use of GDR's machines and tests, such as JLC has kindly posted about a short while ago.
You are right in that we all need a little more patience but we also need to make sure that the 'research' we do is accurate and that you try to comprehend correctly what little information is passed to the market. Also perhaps try not to imply others are wrong when you yourself clearly admit you did some 'research' back in the summer, made some 'calculations' (would love to have seen those...blue crayon or red?) and came up with some share predictions which you then freely admit all turned out to be completely wrong. My green bin calls for yet another resident... Shame after what was basically a very easy and pleasant exchange of posts over the weekend to get back to the idiot traders posting their assumptions based on about 20mins of reading sporadic comms from the company and selected posts on an anonymous bb.
All eyes on Oct 31st and for now forget about FDA
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