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Re: Some new Yescarta dataWell, I'm not wrong, and I don't think JUNO will get FDA approval. Changing the names of their drug doesn't fool the FDA. Their drug and trials are not successful in my opinion. KITE is the commercial leader, has ironed out the CRS issues, and being first in the market means there is no need for an inferior JUNO CAR T - that is not as good (CR) and effective. FDA should not approve JUNO. What ever happened to JUNO's CAR T? Back in Nov. 2014 JCAR015 received a breakthrough therapy designation from the FDA as a treatment for patients with relapsed or refractory B-cell acute lymphoblastic leukemia (ALL). Here's Celgene's latest report on their CAR T from June 8, 2019. It doesn't appear to me that there has been any great advancement. https://www.marketwatch.com/press-release/united-states-celgene-announces-data-from-ongoing-studies-of-liso -cel-in-patients-with-difficult-to-treat-blood-cancers-at-asco-2019-2019-06-08 Note JUNO's MRD is only 75%. How do they expect to get FDA approval with an MRD of 75%? KITE's YESCARTA has 100% MRD. You must think the FDA is blind to all this? |
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