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CTI/Baxalta MF drug on full clinical hold from FDA due to possible excess mortality. bp

This is about pacritnib?

Yes, full clinical hold. Also please see my response to your prior note. bp

Fisher to clarify, pacritinib is on FULL clinical hold not partial. This means as you know all patients must discontinue the drug. Big difference from the partial hold to which fda subjected Gern.

Bio, the Citi press release says it's a partial hold.

SEATTLE, Feb. 8, 2016 /PRNewswire/ -- CTI BioPharma Corp. (CTI BioPharma) (NASDAQ and MTA:CTIC) today announced that the Company received written communication from the U.S. Food and Drug Administration (FDA) on February 4, 2016, that the FDA has placed a partial clinical hold on the clinical studies being conducted under the Company's Investigational New Drug ("IND") application for pacritinib. This clinical hold impacts part of the clinical work currently being conducted under the IND and will also affect planned clinical trials.

You can read more in the post from 8 February on this board.

Not so fast Kemosabe:

SEATTLE, Feb. 9, 2016 /PRNewswire/ -- CTI BioPharma Corp. (CTI BioPharma) (NASDAQ and MTA: CTIC) today provided an update regarding the clinical studies being conducted under the Company's Investigational New Drug ("IND") application for pacritinib. Following the issuance of the Company's February 8, 2016, press release describing the partial clinical hold issued by the U.S. Food and Drug Administration (FDA) regarding those clinical studies, the Company received an oral communication from the FDA followed by a letter notifying the Company that the Company's IND for pacritinib has been placed on full clinical hold. The Company has withdrawn its New Drug Application (NDA) until the Company has had a chance to review the safety and efficacy data from the PERSIST-2 Phase 3 clinical trial and decide next steps.

The FDA's February 8, 2016, letter notes the interim overall survival results from PERSIST-2 show a detrimental effect on survival consistent with the results from PERSIST-1. The deaths in PERSIST-2 in pacritinib-treated patients include intracranial hemorrhage, cardiac failure and cardiac arrest. The FDA made recommendations that supersede the recommendations made by the FDA in connection with the partial clinical hold imposed by the FDA on February 4, 2016. The current recommendations include conducting dose exploration studies for pacritinib in patients with myelofibrosis, submitting final study reports and datasets for PERSIST-1 and PERSIST-2, providing certain notifications, revising relevant statements in the related Investigator's Brochure and informed consent documents and making certain modifications to protocols. In addition, the FDA recommended that the Company request a meeting prior to submitting a response to full clinical hold.

Under the full clinical hold, all patients currently on pacritinib must discontinue pacritinib immediately and no patients can be enrolled or start pacritinib as initial or crossover treatment.

All clinical investigators worldwide have been delivered a notice of the full clinical hold.

Wow, you are right, Bio. I missed that second press release. Doesn't look good for pacritinib....

Link: http://www.prnewswire.com/news-releases ... 17839.html

(btw: who is Kemosabe?)

Fisher, you must not have "the Lone Ranger" in Europe. With a hat tip to Jay Silverheels, it means "one who looks out in solitude" or "trusted scout" with a few other variations also. Regards, bp

I see...Tx