Anavex Life Sciences Corp (AVXL)

[Doc328]

You might want to re-read the article referenced. Here's a link and a quote below

HOUSTON (TheStreet) -- The prestigious MD Anderson Cancer Center issued a stern rebuke to Northwest Biotherapeutics (NWBO) for making promotional, unjustified claims about results from an ongoing clinical trial of an experimental cancer vaccine known as DCVax-Direct.

"I have read the information that the company has put in the public domain. It is extremely unusual and inappropriate," said Dr. Aman Buzdar, vice president of clinical research at MD Anderson, a unit of the University of Texas system. Buzdar, an oncologist by training, spoke by phone about Northwest Bio on Wednesday.

MD Anderson is running the DCVax-Direct phase I/II clinical trial with funding from Northwest Bio, which makes the hospital's criticism of the company's tactics even more significant.

Northwest Bio has issued five press releases and held a conference call in the past month to disclose preliminary and unconfirmed results from individual cancer patients who have had single, inoperable tumors injected repeatedly with DCVax-Direct. Some of the injected tumors have reportedly shrunk, while others have no evidence of live cancer cells present, Northwest Bio claims. [None of the treated tumors have responded to DCVax-Direct using standard definitions used in clinical trials.]

But Buzdar said investigators at MD Anderson and the two other hospitals conducting the DCVAX-Direct study have not reviewed or analyzed data at all because patients are still being enrolled and treated. The statements being made by Northwest Bio about DCVax-Direct are derived from patient case report forms, which the hospitals are obliged to send to the company because it sponsored the study.

There is no overlap between the NWBO issues and the lack of transparency with the Anavex AD results. One is a company publicly releasing selected results while a trial is in progress and another is a company stating endpoints have been met while refusing to release needed details of those endpoints to back the claim. The NWBO issues is too much cherry picked premature "transparency" and AVXL is more standard definition of lack of transparency.

Anavex's investigator McFarlane did prematurely release some information while the study was being performed a couple years back (something to effect that patients with more side effects like dizziness were doing better clinically). That was wrong of him to do so as patients/caregivers in the study could be influenced, but an order of magnitude less inappropriate than what NWBO is accused of doing (premature patient specific data).