Im thinking opposite, i think they approve before. So again...

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bretto32

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17/08/20

16:29

Post #: 46598492
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Originally posted by AndyL2880: ↑

All my own opinion.

Throwing some thoughts out there.

I wonder if FDA will wait until after interim results for Covid-19 results are released before they make a decision for aGVHD.

Why am I wondering that?
- Covid-19 interim results are 'mid September' (seems to be the consensus floating around) thus before the official Sep 30th decision date
- aGVHD and Covid-19 are same treatment
- FDA and raised concerns regarding efficacy within aGVHD (I read all the documentation, listened to the entire ODAC meeting, I don't need a recap here, I understand their concerns and the counter arguments)
- If I were the FDA, I would wait and see the results of the Covid-19 trial

If Covid-19 comes back showing a statistically significant benefit (does not even need to be overwhelming) then it would be near impossible for the FDA to not give approval for aGVHD. This then this would greatly improve the pathway for use with Covid-19/ARDS. For me this makes the interim results for Covid-19 critical for a good number of reasons. Fingers crossed!

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Im thinking opposite, i think they approve before. So again entirely my own opinion...

Sept 4 Approval for Ped. SR AGVHD.
The week after - interim read out for Covid ARDS.

MY thought process is someone whispers to the FDA, we really need this to be a smooth transition, if results are good we want to be dosing people asap. The easiest way is if this is already approved for use.

The beauty of this is we will know in the next few weeks if this is the case.

MSB Price at posting: $4.91 Sentiment: Hold Disclosure: Held
26 Upvote

2 Great analysis

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