BioWatch: Cell Therapeutics Versus FDA, Before ASCO (CTICD)

Health and Healthcare

Published: May 24, 2011 7:40 am

Cell Therapeutics, Inc. (NASDAQ: CTICD) has been very active since its recent 1-for-6 reverse stock split took place on May 16, 2011. Its share volume has increased on all but one of the last six trading sessions, although its price has risen in four of the last six sessions. Monday’s 13.9+ million shares may be hard to top as we have shares taking a breather in the Tuesday pre-market session.

What is driving shares is that the FDA Office of Oncology Drug Products is meeting with the company in early June to discuss the re-submission of its New Drug Application for pixantrone for accelerated approval to treat patients with relapsed or refractory aggressive non-Hodgkin’s lymphoma.

The FDA meeting is after received a response to the appeal announced on May 3, 2011, Whether or not this leads to an approval is one thing, but the company is now allowed to resubmit its new drug application for approval by the FDA with additional information based on pixantrone’s PIX 301 trial.

The FDA has requested that Cell Therapeutics submit two items… “an additional review of radiographs by an independent panel and additional information regarding circumstances of stopping the clinical trial prior to achieving the planned accrual to assure reviewers that efficacy assessments were not involved in the decision to stop accrual early.”

Cell Therapeutics is also presenting data on OPAXIO and Tosedostat at ASCO next week, and that may act as an additional share-moving event.

It seems unlikely that another 13.9 million shares will be seen all over again as we saw on Monday without any fresh news hitting the tape, but the market gods may have the determining factor there. Cell Therapeutics’ shares are indicated down at $2.07 on almost 45,000 shares with about two hours until the market opens. Shares closed at $2.26 on Monday and the adjusted 52-week trading range after the reverse split is $1.26 to $3.30 and the market cap was about $378 million as of Monday.

JON C. OGG

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