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Ann: FDA Notifies Clinical Data Sufficient for Refiling aGVHD BLA, page-719

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nippy

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29/05/24

11:15

Post #: 74060279
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Originally posted by JB1975: ↑

"the CRL did not question the efficiency of the product as was demonstrated in GVHD001"

These words of yours, you appear to be attributing to Phillip Krause on a certain date (you are doing a time line). But note you've written efficiency not effective - and those words aren't the same things although that are often confused. It could be you are accurately remembering or have relistened to what Phillip Krause said in conference and that he got the word wrong, saying efficiency rather than effective or efficacious or it could be you have sort of typo'd. A link to your source would tell us.

I vaguely remember listening to Phillip Krause and think you might actually be attributing the right word to him - and so faithfully passing on his error.

I've no problem with you using material from webinars etc to establish facts about what Phillip Krause or Silviu or Rose actually say, I've done that, I got a key insight into "problems" with the potency assay from hearing Rose say that, (and he said it years after the first CRL and it was never repeated in those words again) but, people make mistakes, clearly, I do, you do, everyone does. And mistakes are sometimes all that it takes - a person doesn't have to be lying (intending to deceive another) to misinterpret something or to make a mistake. Those genuinely believing something themselves however wrongly are not lying if they relate their belief to others.

Being subjective we can all sort of unintentionally lie to ourselves.

SI arguably had - not that long ago - I think he still has - that's my opinion - a very large part of his life's work on the line. Another CRL or running out of money might see someone else decide to take his life's work out of his hands because they think they can do it better.

IF GG has openly declared himself to be in favor of the management team and their approach and SI specifically then he might be positioning for a change because he thinks new management might do a better job - that might cause existing management to want to buy in support of what they consider to be a substantial part of their lives work.

MSB does have a relevant TNFR1 related potency assay patent in the United States now. That in my opinion is an asset - and I don't recall MSB even announcing when it was granted.

Human error though is possible. People make mistakes in judgement and interpretation. But science and stats, done correctly will not find something to be impossible if it is not. And lines of reasoning in science and stats can be laid out and checked. The like button counts won't be the determinant of truth and valid lines of reasoning relating to science and stats though.

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Pretty sure this auto type thing has been covered already.

~~Grease~~/efficacy is the word.

MSB Price at posting: $1.29 Sentiment: Buy Disclosure: Held
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Ann: FDA Notifies Clinical Data Sufficient for Refiling aGVHD BLA, page-719

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