Based on this transcription I did from Si video presentation it...

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17/04/24

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Post #: 73380839
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Originally posted by Stellowe: ↑

but why would he refer to labelling being so important for safety for much more wider use, if he's thinking it will only be available in a handful of hospitals where they have training with gvhd.

administration is a simple thaw and IV process. (excluding targeted delivery)
what safety risk would doctors be concerned with
ards trial was administered in 21 hospitals so there is at least that many with experience..

i think off label use could expand quicker than some people are expecting. maybe not as big as ozempic for weight loss. there just isn't enough resources to run trials for every inflammatory condition. but evidence from off label use could be as powerful.

Off-label practice constitutes a starting point for future research and directions into marketing certain drug products for new indications, shifting to drug repurposing. There have been cases in which off-label use led to drug repurposing [48]; however, in most of the cases, the drug repurposing is triggered by serendipitous discoveries (e.g., thalidomide, *word disallowed by google). *word disallowed by google has been originally approved for pulmonary hypertension and then repurposed for erectile dysfunction [96]. Contradictorily, off-label practice could also lead to off-label use. In the European regulatory framework, drug repurposing can be translated into clinical practice in two ways: approving the new indication and granting market authorization or allowing the new indication to be off-label, based on national regulations [62,97]. All these considered, a repurposed drug product will not necessarily be exempted from off-label use, i.e., a pharmaceutical company approves the new indication, yet the availability of other generic drugs can still lead to off-label use of the generic drugs, if the approved drug is not specifically requested as prescriber’s means to an end [97]. Furthermore, if a certain company does not invest in developing the new therapeutic indication, the off-label prescribing of their product may be beneficial, as it expands the addressability to new categories of patients, without having to apply for a new marketing authorization [97].

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Based on this transcription I did from Si video presentation it appears Si ascribes some of FDA behaviour to anticipated widespread off label use after BLA - whether he anticipates same scale, dont know.

"But I think you know you need to appreciate the product even when its approved for children will be available for hospitals and users for much more, much wider use and I think the FDA want to be certain that when they release this product on the market its widespread use will come with potency assays and disclaimers that allow it be used safely."

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