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Just want to clear up something that seems to confuse people....

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LearningEachDay

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24/12/20

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Post #: 49800872
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Originally posted by jwoody1000: ↑

si/perrin mentioned that the FDA were mostly interested in the secondary endpiont of mortality. (not as much rehospitalization for which there were good outcome for also),
EUA will be sort on the mortality, bases if the FDA hold to what was advised. ... maybe another trial could force again on rehospitalization with early intervention as suggested to be more meaningful and and better chance to reverse damage- not leave it to last treatment when damages becomes to problematic, it seems on this outcome of hospitalization level the trial was more about the other treatment not MSB participation. (would have been better to go this trail alone? without someone else design to failure- msb of course would had to agree at some point- with too much confidence in outcomes regardless of parameters or design of trail)
interest on how they evaluated the rest of the corrputed data, and even publish, what line will it take.
the mortality rate is far superior to anything out there.
the problem is the FDA of course, have rejected kids lives as less important than data endpoints in that case.I'm bias of course, but with others getting approval just becuase the desiged a trial to meets their outcomes to gets approval, regardless of it really works or of benefit or at very low outcome sticks in my throat.

question will be around how to resue all this... will the FDA work with us. or support those that follow in the timeline to coming result of other trails... wasn't there a conflict of interest with FDA members having assocation with other companies on same path.

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Just want to clear up something that seems to confuse people.

EUA is not relevant for CHF. It is only relevant for public health emergencies like we have with the Covid 19 pandemic.

You can learn more about EUA here:

https://hotcopper.com.au/threads/emergency-use-authorization-and-other-approvals.5591703/

What SI is talking about for CHF is accelerated approval, different process/procedures. Same thing we are currently seeking for Ryoncil in pediatric GVHD.

MSB Price at posting: $2.35 Sentiment: Buy Disclosure: Held
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Just want to clear up something that seems to confuse people....

Week 31 Wrap: JORC rules to get tougher; RBA rate hike chance 50/50; US Fed Sept cut still the quo

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Just want to clear up something that seems to confuse people....

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GreenX picks up prospective copper project in Germany

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