Replies to post #3114 on Biotech Values

[zebra4o1]

Dew, does the advisory committe just vote up and down? Can't they recommend that more data is required - sort of equivalent to an 'approvable' letter?

Your 23.75% figure is only half the data I need to make make a rational decision on the puts. I also need to guess what the price of Eyetech shares would be after a bad meeting. Want to apply your backgammon reckoning skills to that number? I think Eyetech has approximately $7 per share cash, so that should be somewhat of a lower bound.

[Skeptic]

Hi Dew - you've got quite a board over here. It seems to be more of a general biotech board than specifically for GENR. I actually don't know anything about GENR but was linked here from the EYET board. I would say one thing about your prediction for panel vote on Aug 27th...

You are predicting there is a 75% chance that the panel will give it a thumbs up and I would say that if that happens, the stock should see a 30% spike which puts it around 41 from today's prices. Why not cover your short now (play the odds) and then put it back in place after the event?

Also - I saw the discussion on CTIC. If you've got some play money, this one has potential. They have four pivotal trials going with data release for all expected in 2005. If just one hits, you'll triple your money or better. I don't think APPX is going to get the nod from the FDA for Abraxane.

[DewDiligence]

FDA rejects Cyberonics depression device

[Apropos to the probabilities I suggested for the non-approval of EYET’s Macugen (#msg-3769444), today’s action on CYBX is one of those cases where the FDA overrules its advisory panel.]

http://biz.yahoo.com/rc/040812/health_cyberonics_2.html

>>
Thursday August 12, 7:44 am ET

NEW YORK, Aug 12 (Reuters) - U.S. regulators have rejected Cyberonics Inc.'s (NasdaqNM:CYBX) experimental device to treat depression, the company said on Thursday, sending its stock down 37 percent in electronic trading before the market opened.

The decision comes as a surprise as an advisory panel to the U.S. Food and Drug Administration had recommended approval of the VNS device, which is already approved to treat epilepsy. The FDA rarely overrules its advisory panels.

The surgically implanted device sends impulses to the vagus nerve and affects neurons in the brain.

Cyberonics had been banking on approval to help fuel its future growth. Chronic depression is a bigger market than epilepsy.

The Houston-based company said the FDA's reasons for rejecting the device included worsening depression in some patients, and potential biases built into the structure of the trial of the device.

In June, an advisory panel ruled that the device was safe to treat chronically depressed patients who had failed other treatments. But some members of the panel were troubled by what they saw as a lack of substantial clinical data to support claims for the effectiveness of the device.

"We are shocked and bewildered by FDA's decision to ignore its expert advisory panel's recommendation," said Robert Cummins, Cyberonics' chief executive officer.

Cyberonics said it is considering all regulatory and legal options to try to get the FDA decision reversed.

Cyberonics shares fell to $15 in electronic trading on Inet after closing on Wednesday at $23.95 on Nasdaq.
<<