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Biotech / Medical : Juno Therapeutics Inc. (JUNO)
JUNO 86.960.0%Mar 6 4:00 PM EST
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To: scaram(o)uche who wrote (47)11/24/2016 4:28:07 PM
From: tuck  Read Replies (1) of 84
 
What if JUNO tried lower dose preconditioning a la KITE?

RBC note on difference between KITE and JUNO approach

Or have they already dismissed that?

Also, here's a paper from earlier this year regarding, in part, the issue that just reared its ugly head again, by JUNO personnel.

CD19 CAR–T cells of defined CD4+:CD8+ composition in adult B cell ALL patients

If JUNO could find biomarkers that worked BEFORE dosing, they'd have something.

KITE plans to file BLA soon. Data is thin, but KITE has accelerated approval hopes. How likely is it that FDA would not accept the filing, issue a CRL, or just plain not approve? I'm thinking it depends on the latest updates at ASH. Implied volatility on December KITE options isn't all that high. Toying with the idea of writing KITE puts. It would be a small bet, even smaller if done before ASH. Need to go look at their abstracts, but it'll have to wait till after Thanksgiving dinner.

Edit: squeezed it in, because KITE gave the link, making it easy:

A Phase 2 Multicenter Trial of KTE-C19 (anti-CD19 CAR T Cells) in Patients With Chemorefractory Primary Mediastinal B-Cell Lymphoma (PMBCL) and Transformed Follicular Lymphoma (TFL): Interim Results From ZUMA-1

Looks pretty copacetic, so a position as described above would be a bet on a black box swan not happening for a few weeks. Hmmm. There's also a DLBCL late breaker, no abstract available in advance. Hmmm.

Cheers, Tuck
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