RE:RE:New Press Release - Theratechnologies Announces Resumed Production of EGRIFTA SV®From the OCTOBER 10 CC transcripts
Looking to 2025, I want to share the latest information we have on the supply of EGRIFTA SV. Our CDMO has reconfirmed it will resume activities mid-October and a manufacturing slot for EGRIFTA SV scheduled for the week of October 21st. Theratechnologies will file a prior authorization supplement or PAS with the review division. The PAS will include the remediation plan implemented by our CDMO, and we expect to submit in early November.
While we expect to have very limited supply of EGRIFTA SV in the latter part of November in terms of ex-factory sales, there will be still a six-week inventory held at the wholesaler and specialty pharmacy level. This will be enough drug to meet patient demand until mid-January. FDA has up to 120 days to approve the PAS and enable the batch to be released. As such, we took the precautionary step to modify or to notify rather the FDA drug shortage staff of the situation and also advise the market.
palinc2000 wrote: 6 weeks later than forecast