3. Q4: Possibly communication of PK modelling results – best outcome would be straightforward PK comparability (AUC[0-inf] 80-120%) – otherwise question is if FDA can be convinced by PD data showing similarity between DPs regarding efficacy-linked immunological markers
https://twitter.com/Chris___Nowak/status/1444914810064445448
4. Possibly (Q1/2022?) communication around another Type A meeting prior to re-submitting BLA to double-check all issues are addressed
5. Re-submission of the BLA (Q1/2022?) and outcome within 6 months (PRVB think may come earlier as CRL did not mention clinical/safety questions).
Personally, I have some questions around Teplizumab’s efficacy in HLA subgroups. In underpowered post-hoc exploratory subgroup analyses of the TN-10 study, it did not delay T1D in persons lacking HLA DR4, see FDA AdCom slide below (but: tiny N, wide CIs &c.) 
And I am really curious about the regulatory strategy for the new-onset T1D indication with the PROTECT study as the pivotal trial given that the FDA does not currently accept C-peptide as the sole primary EP in pivotal trials.
I am involved in consortia that try to provide FDA/EMA with enough evidence to allow them to accept C-peptide preservation as a sole primary (surrogate) EP - but we are a few years removed from that to happen (I think) and both FDA and EMA have made clear
that C-peptide is not currently considered a reasonably likely surrogate EP (in the accelerated approval/cMA context). What is Provention’s strategy here given that C-peptide preservation is the sole primary EP of PROTECT?
Do they think the FDA will have changed their mind by the time they’ve read out PROTECT and file for approval? Have they received any indication from the FDA that applying with a single pivotal trial with only C-peptide preservation as primary EP is acceptable
(which would be contrary to official communications from the FDA, e.g. at the recent Critical Path Institute workshop on C-peptide). That would be interesting to hear more about.
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