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dangerM

01/30/18 8:22 PM

#216957 RE: DewDiligence #216954

... and there has been some more than five-fold volume today for Kiadis (working on therapies adjunct to HSCT as well) _before_ this news and on actually no news for Kiadis itself. This seems very, very quaint.

This was mentioned on twitter, same with another comment on the rate of encephalopathy of CAR-T therapies (www.gilead.com/news/press-releases/2017/10/kites-yescarta-axicabtagene-ciloleucel-becomes-first-car-t-therapy-approved-by-the-fda-for-the-treatment-of-adult-patients-with-relapsed-or-refractory-large-bcell-lymphoma-after-two-or-more-lines-of-systemic-therapy), though BPX-501 is not the typical CAR-T (but adjunct to HSCT for immune reconstitution).

glass_half_full

01/30/18 8:45 PM

#216960 RE: DewDiligence #216954

So I'm going to go ahead and blame Harvey Berger here.

Fight me.

alternatepatel

01/31/18 5:23 AM

#216964 RE: DewDiligence #216954

BLCM: encephalopathy reminds me of Impact-Celgene story

lgonber

01/31/18 7:19 AM

#216966 RE: DewDiligence #216954

BLCM. I remember going through that when holding JUNO. Stock went from $30 to $20 on a clinical hold because of 2 patients death. The stock recovered 7 months after the clinical hold. And as we all know, it got BO last week at $86. Not saying is exactly the same, plus that BLCM program on hold is not a "strict" CAR-T cell program. But, I think it will recover.
I have the impression thought that KITE and JUNO are loved and BLCM has no love in the stock Market (actually the 2 first have been taken already)

DewDiligence

02/23/18 9:36 AM

#217459 RE: DewDiligence #216954

BLCM +9% on BPX-501 clinical-hold update:

https://finance.yahoo.com/news/bellicum-announces-clinical-hold-u-120000591.html

To address the FDA requirements, the Company plans to implement revisions to the U.S. study protocols, including the addition of more comprehensive monitoring and management of neurotoxicity. In addition, the Company will revise the Investigator Brochure and Informed Consent Documents to inform healthcare providers, patients and caregivers of the changes. The Company expects to provide a full response to the FDA within a few weeks.

The hold itself has not yet been lifted.