Jun. 4 at 10:18 PM
$SVRA
"(1) SVRA expects to receive the FDA Type A meeting minutes by Aug 25, 2025, or within 90 days of the May 27 refuse-to-file (RTF) letter. Mgmt will submit a Type A meeting request within 30 days of the RTF, followed by another 30 days for the FDA to grant a meeting and an add'l 30 days for the formal meeting minutes..... we can expect SVRA to update the Street by Aug 25, 2025. SVRA has been conversing with the members of DPACC pulmonology/allergy division at CDER (vs CBER). Ultimately,... once BLA refiles in Q4:25. Our precedent analysis suggests this timeline seems doable.
(2) The RTF seems related to mgmt's oversight more than anything. The FDA's requests are unrelated to any clinical trial, safety, or inconsistent CMC issues. Rather, the RTF is due to 'in-process' analytical testing being incomplete. Instead, the FDA wanted the data now. In any case, SVRA should complete in-process testing by Q3:25." tsai