Careful what you ask for re the daily runs@Wilba32
Great post re Motley interview, thankyou.
Two things stood out.
First, here was another patient ( woo hoo) who had no cover ( boo hoo) but we provided treatment at our cost ( hooray).
Second, the meeting with the FDA has not been held as yet.
Maybe a third item- it was the way Si described " And we will continue to study and do one more study to validate and confirm the initial
findings of an 80% reduction in heart attacks"
Now we know that we are hopeful for an AA with a confirmatory trial. But , to me, this was phrased in a way that a study will take place regardless and the primary end point will be reduction in heart attacks.
My non medical training has kicked in- don't use reduction in strokes nor death as endpoints as these can be caused by other factors.
Revascor is treating heart function- reduce heart attacks, get approved.
I see a Big Daddy Pharma perched on Silviu's shoulder here. The meeting with the FDA is for clarity on Revascor - potency assays , CMC items- similar to the issues they had to navigate with Ryoncil.
I was pinning my hopes on an AA, now I think a global heart partnership is waiting on the outcome of that meeting, whether there is an opportunity to file for a AA or not.
Beware my massive confirmation bias- purchase at your own peril- please, as my wealth increases when you do.
One more thing- when discussing pricing, Silviu mentioned you can put a value on ten more years of saved lives- is that in his head for kids or maybe meant for end stage heart patients??
Shorts think they have two and a half months to exit- I reckon less than 6 weeks as the FDA meeting was requested last quarter and Type B meetings get held within 60 days from receipt of the request. Then 30 days for minutes.
Reg- now rocking air pods, should have bought Apple shares
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Price($) | Vol. | No. |
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10 | 116615 | 1.640 |
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Price($) | Vol. | No. |
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1.660 | 16415 | 4 |
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