Hi
@Bazsa,
I tried to link to your
Post #:61771630, but HC killed it for some reason.
I agree with you that people should digest the information - slowly. Expectations of grand, new ASX/Nasdaq announcements at these calls are IMO misplaced. Those kinds of market announcements are specifically event-driven e.g. BLA resubmission filing by MSB, BLA resubmisson acceptance as filed by FDA, &, of course, BLA resubmission decision by FDA in due course. IMO we will see a progression of these kinds of particular announcements shortly, and the Q3 call contained nothing I can see that indicated otherwise.
Yet, as I see it, exec. management finds a way to get a more granular message across to those interested in sieving the content. So, although it was largely retrospective (being a quarterly review), there was - fore example - so much more in the actual comments by Dr Rose yesterday (approx. 42:02min. into the call - link
here) i.e.
" (Dr Eric Rose, CMO)
I think, ultimately, approval will be based on a totality of the evidence. And we, as shown at the panel, the clinical data are quite convincing.
The potency assay that we originally proposed had problems, and we've reverted to a new potency assay that speaks to the mechanism of action of the cells as an anti-T cell entity.
And we've also been able to demonstrate a clinical correlation between the potency assay and outcomes when measured by disease severity measured by stage, or by MAP score.
And lastly, we've overcome some supply chain issues that have been required to finish the potency assay for the inventory that we've already built for the commercial product that we're in the process now of validating.
And those 3 things, clinical effectiveness, potency assay and reagents to actually do the potency assay on our existing inventory, we think, will carry the day. And as a totality of the evidence, particularly for a patient group that is this sick and then has this high mortality and this high morbidity, we feel confident in the product. "
Yesterday I called these comments by Dr Rose 'generous', but in reality they're much more than that. They are a blueprint for the resubmission highights in MSB's immediate future. CEO Itescu indirectly corrected John Hester's gormless comment & clarified that it will be Dr Rose - & not Dr Krause - who will be leading that resubmission, which is entirely proper and should be appreciated by Marks & Co. at the FDA. No doubt Phil Krause (or 'Phil' as CEO Itescu referred to him as in passing to Eric Rose - as if to demonstrate to the maket the closeness of their 3-way relationship) is up to his armpits in this resubmission. Dr Kause personally made that expressly as clear as he could in his public acceptance of a Board position. There was no need to ask the question again IMO.
But, again IMO it would be utterly reckless (arguably contemptuous) brinksmanship for MSB to standup Dr Krause, with his departure still fresh in FDA minds (& no doubt non-disclosure/ non-compete obligations etc), as the frontman to the FDA on the BLA resubmission. This is not a war with the FDA. I don't know what BP was thinking, but thankfully CEO Itescu realised that BP's questioning had ignorantly managed to slag not just one, but both of the key MSB exec. personnel on whose near-future actions the short-term success of the corporation will depend.
So, against that background Dr Rose reply was gracious and professional in the extreme. He clearly wants & has accepted the authority to present the BLA resubmission dossier being prepared under his supervision.
I'll comment separately on the individual highlights.
(20min delay)