Needle,
I agree with you regarding the pain drug. I had always calculated that ACV1 would eventually add around $3.00 to the value of MBP shares, but I had assumed that the cost of carrying this drug forward through the Phase 2b trials, thus achieving a high degree of de-risking, could be funded out of revenues generated by AOD9604 - which by all rights should be partnered by now.
Now that this possibility has been dealt out of the deck, Metabolic most likely will be forced to partner ACV1 prematurely, giving away a good deal of its potential for the company.
I agree with witch that the share price COULD go as low as 10 cents, but I don't think it will go that cold, largely because there will be a very good indication of the efficacy and safety of ACV1 demonstrated before the end of June. If ACV1 looks good in June, it will most likely continue to look good right on through commercialisation.
Where I disagree with needle is in the assertion that AOD9604 doesn't or didn't work. It works just fine. It has been researched in fine detail and demonstrated over and over again through a period of 17 years, at least. The drug is effective and safe.
It is also a peptide drug. It is almost unheard of for a peptide drug to fail to go to commercialisation at this stage of development, and when they do fail it is due to cost or complications of manufacture, contraindications or side effects, maybe toxic effects close to the theraputic dose, patent challenges by other drug companies, maybe a few other reasons.
One reason peptide drugs DON'T fail at this stage is that they lack efficacy. By this stage, efficacy is known.
This drug has been shelved for one reason and one reason only. It was not tested in a way that would expose, highlight, and demonstrate its "unique mode of action", a phrase I have heard Dr. Roland Scollay use on numerous occasions. Dr. Scollay should have paid more attention to his own rhetoric.
The last trial was a complete waste of time and money. I wish I had better understood waht the company was doing ahead of the game. I would have dumped the stock well ahead of the announcement, because the outcome was preordained by the trial design.
The trial design essentially superimposed two weight loss regimes that do not synergize. One, AOD9604; the second, a closely supervised, enforced lifestyle modification programme. AOD9604 effectuates lipolysis, and as far as I know, that's all it does with relevance to weight management.
Someone wishing to lose weight will still need to do all the normal things; diet, exercise, etc. in order to make it happen. What AOD9604 will make possible is for a dieter to eat less and lose more. If the ADO9604 treated population is forced to eat and exercise the same as the control population, the result in both populations will be identical. No result.
And, this approach is NOT mandated by the US FDA. Quite the contrary, their guidance on development of weight management treatments, released less that two weeks before Metabolic pulled the plug on AOD9604, is very clear that trial protocols should basically conform to expected real-world treatment protocols.
An effective trial would need to open the door to patient initiative and enthusiasm to take their individual diets as far aas they can, just as dieters do in the real world.
I guarantee that with a bit of imagination company scientists can come up with a trial protocol that would demonstrate with statiscial significance, the weight loss characterisitcs needed to firmly establish AOD9604 as the weight loss drug of choice.
The company's decision to throw in the towel was premature and ill considered. That the last trial was a failure is not in dispute. But the reason that the trial failed is not that the drug doesn't work.
I don't know that I would characerise this as a rose colored view. I find it most discouraging and depressing. I wouldn't mind so much if it actually had failed. But to see the drug abandoned for no good reason is appalling.
Needle,I agree with you regarding the pain drug. I had always...
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