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Friday, April 21, 2017 11:54:01 AM
Not to be "negative Nellie" here in terms of time wise, but according to this article (completely different drug/therapy), when you ENTER phase III, you are talking about a 2-3 year process. IF from what I understand, this restriction or whatever it was, was just lifted from USRM correct?
If it was JUST lifted and NOW they are going to enter this phase, I would think even an RMAT approval would be a ways down the road?
Again, from what I understand clinical trials can take awhile and maybe they already have them going on, but to me, I think this recent $5 million dollars is meant to put towards the trials as they are the most expensive part of the whole process (phase III I'm talking). In the example posted below, this one needed anywhere from $20 - $25 million. No chump change. That's why the whole bowl of wax is based on the results of Phase III. IF it is successful and you get approval, well we all know what would happen and that's why we are here.
I just don't think it's going to be just a few months here. Could be couple of years UNLESS, this cell stem process is SO successful, the medical community and the human race for that matter absolutely needs it. That would surely need to have earth-shattering results IMO.
Hope I'm wrong on timeframe as really want my Land Rover!
Have good weekend as only ONE post left. Here is the link I found:
http://www.maps.org/research/mdma/ptsd/6480-fda-agrees-to-phase-3-trials-of-mdma-assisted-psychotherapy-for-ptsd
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