Apr. 2 at 2:21 PM
$TRAW
For those worried about the clinical hold. 80% chance it’s lifted. That’s good odds at this price action!!!
Clinical holds related to safety, including mutagenicity and other preclinical data concerns, have a high likelihood of being lifted—roughly 80%—typically within 5 to 6 months. While holds are intended to protect patients, they are generally resolved once sponsors submit protocol amendments or additional data to address FDA concerns.
Key Takeaways for Clinical Holds:
Lift Rate: Approximately 80% of cell and gene therapy holds (2020-2022) were lifted.
Duration: The average hold lasts about 6.2 months.
We are at 1.5 months. TXM had a lot of momentum and financial backing!
Resolution: Lifting usually requires submitting protocol amendments, additional preclinical data, or updating [chemistry, manufacturing, and controls (CMC)].
FDA Response Time: FDA has 30 days to review a complete response to a hold.
*NFA
