metabolic works, page-4

Witch-

Interesting post. I wrote to the company a couple days ago, but no response yet. I think their answer would be along the lines of wwhat they told you.

I am still optimistic about ACV1 and in fact I had reached the conclusion that AOD9604 was abandoned prematurely.

Reading between the lines, though, and keeping in mind your remarks about FDA regulations regarding testing weight loss drugs, I think the company already has a good idea that we have a way into the market through the osteoporosis door, and once there, the drug will wind up prescribes "off-label" for diet.

I think I will be buying more shares at the present prices.

Here's the letter I sent to Roland Scollay:

Dear Dr. Scollay,

Dr. Scollay, please excuse my direct approach, but I hope that holding xxx,xxx shares might permit me this indiscretion.

The Board of Director's decision to terminate development of AOD9604 for obesity seems to me a short-sighted and profoundly regrettable act of corporate petulance.

To be sure, every member of the Board must have been deeply disappointed at the results of the recent trial. Of this there is no doubt. But there was no compelling reason to "throw in the towel".

In truth, the recent trial succeeded only in proving that a tightly controlled weight loss trial can drive even a placebo group to success. Beyond this fact, the trial proved nothing, and it most certainly did not demonstrate any lack of efficacy of AOD9604. The weight loss achieved in this trial by the treated groups was comparable to the loss achieved in the 2004 trial.

The result of the present trial for the placebo group and the treated groups alike was constrained from the start by the trial conditions.

Predictably, as members of the treated groups were limited by the trial protocol from fully manifesting the benefits of AOD9604, the lipolysis enhancing effect of the drug was never really tested. Just as predictably, the tightly controlled nature of the trial enhanced and prolonged the placebo effect. I am not aware of any weight loss trial of similar duration where the placebo group had this much success.

The company alludes to as much in the trial announcement with the remark that the effects of the drug could have been "overwhelmed by the effective weight loss programme". The effect of the AOD9604 was most certainly masked in just this way when all trial participants were gang-marched in identical leg-irons. This masking of the drug effect appears to have rendered the entire trial nearly worthless.

A truly effective and persuasive trial of AOD9604 would need to mimic real-world conditions. A trial designed to reveal and confirm the effects of AOD9604 might start by establishing a weight loss target, say 0.5kg per week, and then turn participants loose to achieve their diet goals as they may desire, over a 12 and 24 week trial period. Trial participants would need to select and control their own diets and freely exercise (or not) with the intent of meeting or exceeding their weight loss targets at a weekly weigh-in. The physician would ensure that participant health was maintained throughout. In such a trial design, the ability of treated participants to more freely access and burn stored fat than the controls would manifest itself in increased success rates and higher rates of weight loss, much as seen in the 2004 trials.

Until such an effective and realistic trial is conducted, no firm conclusion can be drawn as to the commercial viability of the drug, contrary to the company's announcement.

What can be said with certainty at this point in time is that the company has irretrievably broken faith with its investors, with the researchers who discovered and described the remarkable properties of ADO9604, and with the millions of everyday people who would have realized immeasurable health benefits from the drug had it been taken to market.

Should the company eventually succeed in bringing AOD9604 to market as a treatment for osteoporosis, you can be absolutely certain that it will be prescribed off-label for weight loss, and with enormous success. Mark this prediction well, as in time it will come to be seen as prescient.

What a shame that Metabolic could not see this project through to success. And the shame is all for the Board of Directors for lacking the courage of their conviction.

Please feel free to share my opinions with the rest of the Board.

Regards,

John Valentine