”Page 33 of the ODAC transcripts confirms the 2014 meeting with the FDA to agree a trial protocol for our open label 001/2 sr GVHD trial. The review committee later moved the goalposts... that is clear ...not Mesoblast.”
@Pledge If you are going to quote me, be kind enough to put the quote in context and include the referenced source in the original post. I explicitly quoted from the published MINUTES of the ODAC hearing from Mesoblast’s testimony. I was not aware, unless you are, (big boy) that the FDA had refuted this account of proceedings !
Re Incyte/ Jakafi the results in Grade 3/4 patients with acute sr GVHD , showed less efficacy and considerably worse adverse events in a single arm trial to Ryoncil and were approved…which is why one of the ODAC committee felt moved to call out the FDA for lack of consistency in its decisions.
As for SI’s view of a couple of weeks… I have recently shared your pessimism for timelines…so what’s your point ?
I have not been able to predict timelines because we do not know exactly what terms and timelines (long stop dates=legal jargon) were agreed between Novartis and Mesoblast with respect to data sharing and subsequent analysis…however SI recently stated that Novartis now have the relevant information..so now we have to allow for what might constitute a reasonable period of time to interrogate these results. In the meantime, there is a far more pressing decision to be made by CEBR/FDA. Is the data from Mesoblasts ARDS Phase three trial sufficient to allow an application for an EUA to proceed or not ? That is a difficult call because the underpowering of trial result combined with an early termination of the trial has to be set against some first in class results in a pre specified secondary endpoint…namely under 65s in a combination therapy of remestemcel-l and dexamethasone . If Mesoblast are intending to meet with the FDA this month as speculated by many posters on this and other forums, I believe it is logical to assume the clinical data must have been verified and extrapolated in advance of this meeting. Therefore , I suggest, rightly or wrongly, that Novartis are now finally in a position, to make a clear evaluation of the efficacy of Remestemcel-l. Will they wait until after the pre EUA meeting or want to be party to those discussions ? I contend the latter. Therefore, you will be pleased to know (sic) that I think Novartis will formally confirm a contractual relationship with Mesoblast in the coming week/s. So, there you have it. My best guess is now in the next two weeks….so don’t forget to give me a bollocking if nothing happens ….not that you will need reminding ! If Mesoblast are allowed to proceed with an EUA application for Covid related ARDS, they have typically been processed in a period of three weeks reflecting the emergency nature of the legislation. Either way, I believe the data is so compelling that Novartis are highly likely to want to be involved with a confirmatory trial which should take less than a year to enrol and complete (owing to the short term nature of the primary endpoint) .
As regards our other indications, i anticipate OTAT should finally set out its stall within the current quarter. I believe that there is confidence in the Mesoblast camp that they understand the likely proposed technical requirements and are able to meet the new “quality attribute” or “potency assay” standard protocol ,which will be vital for the CMC module of any subsequent BLA application. I would hope that confidence would have come from agreeing protocols and initiating internal high throughput testing runs BEFORE oncoming meetings to show themselves capable of achieving the likely new standards (one of Steven Bauer’s pet projects it appears)
I always find it amusing that critics of the company expect Mesoblast to invest hundreds of millions in large scale 3D Bioreactor runs, when the FDA has not yet opined on whether the resulting inventory will have been generated under supervisory protocols which will allow them to be used. It is obvious to me, that an audit trail will be a specific requirement, to allow precise traceability of each and every vial produced so that the cells can be attributed to the donor source at all times.
As to our other “multiple shots on goal”. I remain extremely confident. Whatever regulatory pathways are established by the FDA for our therapeutics in coming months will determine much more clearly the commercial value of our proposition to both investors and partners alike. I believe this will be the inflexion point that I have been waiting for.
Please do not rely on the accuracy of any opinions or facts expressed in the above post when making an investment decision. OP
MSB Price at posting:
$2.02 Sentiment: Buy Disclosure: Held
(20min delay)