"in the 7th of March 2024 - potency assays was what they were going to the FDA about."
And then after that meeting, we get the announcement about "appears sufficient."But they didn't say the potency assays appears sufficient or it appears that there is now sufficient evidence for us to consider it validated or anything at all with the words potency assay in it did they? And why not if it was the concern as late as 7th March?
And then after that meeting, we get the announcement about "appears sufficient."Have you considered that"remaining product charactisation issues" 27 March 2024 -
might just mean the resubmission will include the data on all the product characterization issues that remained after CRL2, consolidating all the data they presented to and discussed with FDA prior to FDA's communication about how the available clinical data "appears sufficient?"
Yes. I've considered it and rejected it as unlikely because either the potency assay remained part of the outstanding product characterisation issues (as at 27 March 2024 - last ASX announcement time) or it didn;t and if it doesn't (then or since) its removal as an outstanding issue would have been such a relief to MSB and the market that they could have and should have (I'd say it would verge on serious nondisclosure) if they didn't said something more explicitly reassuring to the market.
After being twice burned, do you really think MSB would refile this quarter if they thought there were "remaining product characterization issues" that hadn't been resolved to the FDA's satisfaction?
MSB shareholders such as yourself have shown a remarkable willingness to keep coming back and Silviu and Philip Krause apparently did either misread the situation (including what the FDA wanted) or punt (weight the competing risks - finances were going to be an issue) before getting CRL # 2, so yes I think they could misread and/or punt again.
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