Hi Stellowe,
There is no chance of a 2 month review in my opinion. Significant changes with potency assay, or product potency testing data is going to need up to 6 months.
HLHS they did not mention in the 4C, but I think ( and as you mentioned ) because it is the same product used for CHF LVAD, and CHF LVAD may get accelerated approval. It makes more sense for the company to get accelerated approval, then label extend. In the meantime off label treatment may occur.
I do think that CIBMTR are pressing ahead with the adult trial, as it is their trial rather than Mesoblasts... just not sure on when or if we will get an update as to the status. Are they waiting for December before starting I wonder ?
Reg -
Mesoblast need to submit the Evidence supplement, and then FDA can assess, but I'm not exactly sure if they have enough evidence now because I don't think they have treated that many adults with the new version of remestemcel compared with children and had positive results?
They have enough funds to last until the expected FDA decision in December, and probably a bit longer now that the loan is payed down slightly and 6 month cash runway figure is less. I think the board etc are remaining on rations until the FDA decision ?
I'm Back-
The type of resubmission and the response times are listed in FDA SOP's. FDA don't have a say as to what MSB are going to provide them, and so I don't think FDA have a say, in choosing to define what MSB have provided as basically a minor update ( I don't think it's minor ). Aug approval would be a lightening bolt out of the blue IMO.
" The classification of a resubmission is based on the information submitted by the applicant in response to an action letter"
"The time frames for completing the review of Class 1 and Class 2 resubmissions were specified as 2 months and 6 months, respectively, per 21 CFR 314.100; the time frame for issuing an acknowledgment letter was changed from 14 days to 30 days; language was added to clarify that a filing determination is not made for resubmissions; minor editorial changes were made to make clearer the process for determining whether a submission constitutes a complete response that addresses all the deficiencies in the complete response letter."
"‒Class 1 Resubmission — A resubmission that includes one or more of the following items: 1. Final printed labeling 2. Draft labeling 3. Safety updates submitted in the same format, including tabulations, as the original safety submission with new data and changes highlighted (except when large amounts of new information, including important new adverse experiences, not previously reported with the product are presented in the resubmission) 4. Stability updates to support provisional or final dating periods
5. Discussions of postmarketing requirements/commitments, including proposals or protocols for such requirements/commitments
6. Assay validation data ............( NOT NEW ASSAY VALIDATION DATA)
7. Final release testing on the last 1 to 2 lots used to support approval
8. A minor re-analysis of data previously submitted to the application (determined by CDER as fitting the Class 1 category) 9. Other minor clarifying information (determined by CDER as fitting the Class 1 category) "
MSB have said numerous times in their updates, that they have provided new data, on a new assay not previoulsy given to the FDA, so I don't think this is a minor re-analysis, it will be completely new data from a previously unheard of potency assay, that will need full FDA analysis from scratch by FDA.
In either case, in August FDA will set a PDUFA date, which could be 31 August to 31 December. ( Based on 30 June resubmission with either 2 or 6 month review )
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