Biotech Values

[Aiming4]

Cortex Concerns - please add yours...

In order to help anyone who's interested in evaluating Cortex, I'd appreciate help in compiling a list of concerns about the company and Ampakines.

Please contribute to the list if you have any general or specific items to add; I will preserve this list on the iHub COR board.

At the moment everything appears to be moving in a positive direction for Cortex and most of the negatives are questions rather than facts, but all are valid concerns.

The negatives I'm aware of include:

Science related:

1. 2004-12-31 (from Dew's recent post) we don’t know whether CX-717 does anything useful in humans.

2. 2004-12-31 (from Dew's recent post) we don’t know whether CX-717 is safe enough for humans to take for an extended period of time.

3. 2004-12-31 (from Dew's recent post) we really don’t know much of consequence yet about whether CX-717 has what it takes to make it commercially.

4. 2004-12-31 Someone on iHub mentioned their concern that Ampakines could have unexpected consequences when amplifying memory, e.g. being hyper-aware, remembering too much minutiae, etc... This was an excellent call out, and one I've kept in the back of my mind since I read it.

5. 2004-12-31 Concerns over potential for abuse, e.g. what happens if someone takes Ampakines to avoid sleep dep for 2 weeks straight?

6. 2004-12-31 AD and Fragile-X indications - very difficult to measure results, very difficult to get legitimate results. Any AD trial is cause for concern due to their high rate of failure.

7. 2004-12-31 MCI indication - healthy subjects have low tolerance for side effects, more difficult to show efficacy in someone whose memory is already pretty good. MCI is a new indication to the FDA, approval may be very difficult for a variety of reasons.

8. 2004-12-31 CX-516 trial failure showed unexpectedly little effect in memory results, plus the trial had a large number of GI side effects.

Company related:

1. 2004-12-31 The potential for fraud, embezzlement, etc... Unfortunately this is a concern with any company.

2. 2004-12-31 Slow trial progress - Cortex in the past partnered out several major indications to Servier and Organon, both of whom have moved very slowly in their trials.

3. 2004-12-31 Diminishing Patent life - not yet a concern, but eventually will become so without continued steady progress toward FDA approval.

4. 2004-12-31 Patent challenge in Europe over Cortex's broad usage patent that has been initially approved, but is subject to amendment or revocation pending the challenge decision.

5. 2004-12-31 Ongoing possibility of additional dilution.

6. 2004-12-31 PIPE concerns - there is some concern that the recent PIPE wasn't necessary, and/or was done at sub-optimal terms.

7. 2004-12-31 Stock options - there is some concern that Dr. Stoll has been granted too many stock options.