That's a very good point. That trial is still bei
Post# of 155563
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Posted On: 06/29/2020 7:49:24 AM
That's a very good point. That trial is still being enrolled and I suspect we are probably in the neighborhood of 100+ at this time. And that is 100+ out of the total 390.
And you're right, it is hard to "sell" the thesis that the FDA back-channeled a go-forward Mexico date entirely based upon the S/C interim readout. So, that leaves me with a somewhat weakened argument that it is due maybe to a combination of the S/C readout, the M/M database lock (in two days), and maybe the somewhat arbitrary date of July 1.
We were originally told that Mexico would possibly approve leronlimab on the basis of a small 25 subject trial and the data from the anecdotal EIND patients. I just don't understand why a country drowning in COVID deaths would waste a full month to start an incredibly short trial that might have entitled them to at least a small allocation of leronlimab.
I suppose this MOU could be Mexico's expression of interest in conducting their own rubber-stamp trial, subject to learning the results of the US trials. This way, they are next on the list if the results are good, but they don't waste time and resources on a trial (as small as it is) if the results are not good.
Somehow, I find the timing of this press release, relative to the two US trials, to be curious. But maybe the timing is being driven by Mexico.
And you're right, it is hard to "sell" the thesis that the FDA back-channeled a go-forward Mexico date entirely based upon the S/C interim readout. So, that leaves me with a somewhat weakened argument that it is due maybe to a combination of the S/C readout, the M/M database lock (in two days), and maybe the somewhat arbitrary date of July 1.
We were originally told that Mexico would possibly approve leronlimab on the basis of a small 25 subject trial and the data from the anecdotal EIND patients. I just don't understand why a country drowning in COVID deaths would waste a full month to start an incredibly short trial that might have entitled them to at least a small allocation of leronlimab.
I suppose this MOU could be Mexico's expression of interest in conducting their own rubber-stamp trial, subject to learning the results of the US trials. This way, they are next on the list if the results are good, but they don't waste time and resources on a trial (as small as it is) if the results are not good.
Somehow, I find the timing of this press release, relative to the two US trials, to be curious. But maybe the timing is being driven by Mexico.
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