(Total Views: 707)
Posted On: 06/29/2020 8:39:49 AM
Post# of 155697
Lorbas,
I think this helps from many fronts. CYDY gave Mexico de same protocols used in the USA. If FDA ask us to complete a 390 patients SEVERE or carry out a P3 M-M we could arguably get some help from patient enrollment in Mexico. The trial can be expended to some hospitals there, recruitment will be VERY fast as they have a very bad pandemic ongoing.
So, the trial in USA could, arguably, be extended to include Mexico (remember, they have the same protocols).
Besides, there is always the healthy pressure on the FDA
Quote:
Anyway, as ohm notes it just seems to be a means to put pressure on FDA... A 25 patient trial is BS when you have the US trials on-going....Don't know why Mexico doesn't simply say that they'll approve if (one of) the US trials are successful.
I think this helps from many fronts. CYDY gave Mexico de same protocols used in the USA. If FDA ask us to complete a 390 patients SEVERE or carry out a P3 M-M we could arguably get some help from patient enrollment in Mexico. The trial can be expended to some hospitals there, recruitment will be VERY fast as they have a very bad pandemic ongoing.
So, the trial in USA could, arguably, be extended to include Mexico (remember, they have the same protocols).
Besides, there is always the healthy pressure on the FDA
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