Re: GENR's hurdles
>> more testing must be done but why would one harp on an issue that does NOT appear to be an issue! <<
Merely saying that it’s not an issue does not make it not an issue. If you are long GENR and are not as least somewhat concerned about long-term systemic safety, I think you’re being remiss.
Shit happens in drug development. Merck recently lost a diabetes drug in phase 3 because of a safety signal they had not detected in earlier trials. Sometimes these problems do not surface until several thousand patients have been tested, which does not happen during phase 2.
How many Squalamine patients have been treated to date? A few hundred at most. If there’s a safety problem that affects only a few patients in a thousand, it’s unlikely we would have seen it yet. Especially if the problem turns up only after extended use.
Finally (and this is a point that many seem to overlook), there does have to be an actual safety problem for the long-term safety issue to derail Squalamine’s prospects. All that’s required is the FDA’s perception that there’s a safety problem.
Given the degree of focus on Macugen’s systemic safety at the August 2004 ophthalmic advisory panel, I think the same panel will maintain a high degree of skepticism about any systemic anti-angiogenic treatment for AMD.
However, this is a pretty long way off and a lot of things could happen to the stock in the interim. Currently, I think GENR’s biggest hurdle is getting the main “209” study enrolled in a timely fashion. The fact that there is a placebo arm in this study is problematic now that Macugen has been approved for all forms of wet AMD. How would you feel about enrolling yourself or a family member in an AMD trial where you might receive only a saline infusion?
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