Many questions unanswered from the FDA report: https://t.co/TxSER3Go0n
Colleagues I've consulted with are very surprised by this as we haven't seen. Questions:
-what was the clinical status of the patients in terms of immunosuppression, prior therapy, conditioning chemotherapy, evidence of prior clonal hematopoiesis?
-some unknown number of patients may not be in follow up as recommended, were there undetected/unknown early warning signs?
-related to the product, what was the vector copy number? Was integration site analysis performed?
*It’s important to put into context the remote though real risk when compared to conventional chemotherapy that has significant long and short term side effects, including genotoxicity and predisposition to secondary cancers.
We are officially in Paris!
We are excited to kick off our pre-meeting day with the ISCT Global Regulators Summit on the Use of Unproven Cell and Gene Products, bringing together experts from 15 regulatory agencies and government agencies from across the globe.
#ISCT2023
Miguel Forte, President-Elect of @ISCTglobal and ARM Board Member, delivered powerful closing remarks today at #ATMPEurope.
1/3 "As a European, as a drug developer, as an assessor, I'm stressed to see state of Europe. We have a duty for our patients, our science to do better."
Bone Therapeutics announces expansion of its pipeline supported by funding from the Walloon Region | Bone Therapeutics agrandit son portefeuille de produits avec le soutien de la Région Wallonne
- https://t.co/CUpHkHT6k9
Dr. Fortems presents results of our Phase II/III clinical trial with our product JTA-004 at the European E-Congress of Rheumatology 2020.
@eular_org#EULAR2020#EULAR2020goesvirtual