These are standard questions or issues that the FDA put up for...

These are standard questions or issues that the FDA put up for most companies. Check the history out. That's what they do. I have attached Cell Therapeutics' FDA issues. They were scheduled with CXS for the 10 Feb too.

Also, I had correspondence with Greg and he is jumping at the bit to present at the ODAC meeting. He seems confident that they can address all of the FDA issues.

I guess time will tell.

I took the opportunity to top up today and average down, not the safest strategy but feel a lot better after discussing with Greg. DYOR!

I have also included an e-mail from Greg today confirming what I said. I suggest people call him on his mobile he is very approachable.

From: Greg Collier [mailto:[email protected]]
Sent: xxxxx
To: xxxxx
Subject: RE: FDA Issues with the submission

xxxx

These are normal FDA questions and consistent with why we are having an ODAC meeting? I am happy to discuss with you if you have questions but we are ready and waiting for the chance to meet with the ODAC committee to discuss the issues in detail. Please check previous company FDA correspondence before ODAC if you want some comparisons to questions and outcomes.

Cheers Greg
Greg R Collier PhD
CEO and Managing Director
ChemGenex Pharmaceuticals Limited
www.chemgenex.com

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http://blogs.wsj.com/health/2010/02/08/tough-questions-await-cell-therapeutics-cancer-drug/

Tough Questions Await Cell Therapeutics Cancer Drug

Cell Therapeutics experimental lymphoma drug pixantrone faces rough sledding from an FDA advisory committee after an agency staff review raised questions about the drugs effectiveness and side effects. The news sent the companys shares sharply lower.

One of the chief studies of the drug was supposed to involve 320 patients but only 140 were enrolled. Cell Therapeutics told the FDA it had trouble finding participants for the study because doctors preferred to use multiple chemotherapy drugs or supportive care, Reuters said, citing the FDA staff summary. Heres the full FDA briefing document.

The study period was also cut short. The FDA said a higher level of evidence is usually required in trials which discontinue prior to final analysis, Dow Jones Newswires said.

Following the FDA staff comments, shares of Cell Therapeutics were trading down more than 25% around midday.

Cell Therapeutics hopes to sell the drug, pixantrone, under the brand name Pixuvri to treat non-Hodgkins lymphoma that has stopped responding to other treatments. The oncology advisory panel is to meet Wednesday. The FDA doesnt have to follow the advice of its advisory panels, but it usually does.