Aug. 7 at 12:52 AM
$GRCE Timeline from the recent announcement
(i) the U.S.-based facility, which would require completion of a full chemistry, manufacturing, and controls (“CMC”) package supported by 12 months of stability data following the technology transfer; or (ii) the Company’s current contract manufacturer, if it successfully remediates its FDA compliance issues and is able to support the NDA sooner. The Company is also advancing efforts to address the remaining CMC and non-clinical items identified in FDA’s Complete Response Letter (“CRL”) to the NDA, though the Company expects that manufacturing readiness, rather than these items, will be the key driver of NDA resubmission timing.
@CharlieeMungerTWITS
The language in point 2 suggests.. manufacturing readiness determines the timeline. The first cdmo (foreign country) requires a FDA reinspection (6-12 months) before resubmission . The second cdmo in the US needs to do cmc + 12 months stability test.
PROBABLY 18 - 24 MONTHS TO APPROVAL
