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Ann: FDA Notifies Clinical Data Sufficient for Refiling aGVHD BLA, page-998

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col69

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16/06/24

13:20

Post #: 74337696
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Originally posted by JB1975 ↑

It would dovetail with the new assay tests which FDA have indicated are sufficient for an approval consideration.

This statement goes beyond what even MSB has said.

Leaving aside that like LearningEachDay did once, you are conflating hearsay (MSB or Silviu's statements (it is not even entirely clear what you are believing as I don't think you credit the reporter Cameron England as a particularly reliable source but you haven't said that) with indications from the FDA, not even MSB have stated that the new assay tests specifically were an sufficient for a new approval consideration.

I think you don't believe and are on record as not believing what Cameron England said about January in The Herald Sun and in The Australian. I could be mistaken about you being on record by I don't think so and it doesn't really matter.

I also don't believe you'd believe an FDA official would speak like Cameron England quoted Silviu as saying (which I've already highlighted).

I took (or tried to show LearningEachDay and pledge) and this forum some relevant figures in a patent application (still ungranted - still trying to get a patent on aspects of the two part potency assay matrix) trying to get them to look critically at the still only 11 dots - and you posted back saying you'd looked and including the dots based figure and noting some differences in the statistics but avoiding acknowledging there were still just 11 dots.

The requirement to show that there has been at least one adequate and well controlled study is on MSB as the applicant - MSB has informed the market previously that problems with the potency assay meant that GVHD-001 couldn't be that trial (I'm not quoting but near enough - both bazra and pfeifer1982 have brought the same paragraph to my attention again recently and separately.

As of this point in time MSB have not said since they were going to meeting to talk about potency assay stuff (as I've shown with Silviu speaking in his own voice in a checkable webinar on 7 March 2024 - Hidden Gems) since then MSB has not said it has a validated potency assay. I think it asserted that prior to the second CRL (because it believed or was intending to argue it did - that it was validated on the evidence) but then the FDA rejected it and they couldn't keep repeating they had a validated potency assay as they were still sorting that out with the FDA - well, they still aren't saying they have a validated potency assay anywhere I've seen since 7 March since 27 March - the potency assay could still be the product characterisation issue (I think it is - because I've looked at the patent applications and there still isn't enough there to validate the potency assay).

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"I don't believe the FDA would" .... "I think" .... etc etc etc

Only the FDA and Mesoblast really know what is going on so you can spread all the FUD through your conjecture all you like - you have been proven wrong so many times by many posters before on the MSB forum ... the PDUFA outcome will come soon enough and only then we will all know for sure but whilst we are all speculating - my guess is it will be a 2 month PDUFA date / turnaround

GLTAH

MSB Price at posting: $1.08 Sentiment: Buy Disclosure: Held
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Ann: FDA Notifies Clinical Data Sufficient for Refiling aGVHD BLA, page-998

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Ann: FDA Notifies Clinical Data Sufficient for Refiling aGVHD BLA, page-998

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Coda Minerals (ASX:COD) enters rights issue to further exploration in South Australia

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