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06/08/23
12:35
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Originally posted by dolcevita
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Yes stay calm when others are losing their heads.
It's not just babies!
IMO It's unethical to run a double blind trial in adults WHERE you have zero risk on safety AND there are zero alternatives and a mortality rate of over 70%. Was it 80% I can't recall now because the stats come in thick and fast and now people are turning on SI forgetting that we have on the Board an ex FDA senior administrator who has been guiding us.
This has been SI's preoccupation to SAVE LIVES. Plus the academics concern too. Plus we has a negotiated outcome on appeal, plus guidance from the underlings as they went through the process and then stymied at the final hurdle.
Hard to predict what the FDA will decide given that it has been all over the place. The decisions they make need to be seen in context of the safety and the unmet needs it defies all reason.
It's clear to me that the FDA do not like being told what to do. They are AMATEURS in relation to this technology which is a world first. You know that!
You also know that SI and team guided the FDA on stem cell policy guidelines and probably inadvertently made them look like fools.
The entire decision is shameful but instead of blaming the FDA given this entire context, people are going in for the kill on SI.
Take a step back and have a rethink please.
This is a CALL FOR CALM. Usually you can be relied on for that and some decent perspective. I'm disppointed in you but nobody's perfect. The company looks like getting funding from the partners in the academic world. They must be aghast at the compound stupidity involved here given that pharmaceutical drugs get routinely waved through. see my points above to LY. SI indicates this funding source in the Corp Comm
stay calm and re listen to the Corp Comm. I have several times and it rewards once you set aside the emotion. IMO.Absolutely correct. Plus MSB forced them to revise by going to appeal, and it seems some in the FDA didn't like it.
This is about professional standing and jealousies as well as vested interests and incompetence.
People are being very reductionist by slicing and dicing every aspect of the technicals and alarmist in their thinking. The legal team and the academics are setting in for a hell of a fight and we should support SI think rationally and try to reduce the bloodletting. There is funding and the rest of the programs will be put on ice from what I heard on the Corp Comm.
This is a David and Goliath fight but people are just in shock. They need to recalibrate, and stop personalising this in an attack on SI.
This is world first technology, we have met their requirements on the production and consistency end.
We have lead the FDA where they were clueless.
We need to step back and see this in greater context on the legals and the technology, you are absolutely correct on the fight ahead.
I have NOT changed my sentiment, or at least changing it back and digging in. There are accumulators out there who are seeing the bigger picture even if M&G cannot.
Correct but breakable is in the wider context, ridiculous. See above.Totally.
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Also I would like Dr Krause's take on all of the process he was involved in
It won’t happen but it would shed a lot of light where at the moment there is darkness