Biotech Values

[DewDiligence]

The “cancer model” does not apply to AMD:

[Reposted from #47736 on Yahoo]

Those who doubt the credibility of the results from GENR’s phase-1/2 trial may misunderstand the nature of AMD. Some investors may improperly be applying the “cancer model” to evaluate the clinical data in AMD.

Cancer patients sometimes undergo spontaneous remission. In a small uncontrolled cancer trial, you simply don’t know whether an observed benefit is attributable to the treatment itself. That’s why cancer drugs often fail to reproduce an observed benefit from early-stage clinical trials when the drugs are subjected to larger patient pools and placebo controls in later-stage trials.

However, patients with AMD do not undergo spontaneous remission. If AMD patients in a clinical trial experience improved vision during a clinical trial, the improvement can be almost certainly be attributed to the therapy.

Placebo arms in AMD trials are used to track how rapidly untreated patients lose vision –not to track how often untreated patients gain vision. The latter essentially doesn't happen.

There is no question that Squalamine works in AMD. What remains in doubt is how long the effect lasts (which dictates how often patients should be retreated) and what is the best dose to balance safety and efficacy.

Investors who apply the “cancer model” and thereby doubt the veracity of Squalamine’s phase-1/2 results in AMD may miss out on a great buying opportunity. By the time the phase-1/2 results are confirmed by the phase-2 trials in the U.S., the stock will not be selling for $4.