Biotech Values

[DewDiligence]

>> When you say you are not sure if there is a dose that is safe, I wonder what side effects you are thinking of. <<

krenjp: The issue is not what side effects I am thinking of, but rather what side effects the FDA is thinking of.

At the risk of sounding repetitive (because this topic has been beaten to death on this message board), I was dismayed at the FDA advisory panel for Macugen by the degree of attention a prominent FDA staffer gave to systemic safety of anti-angiogenic drugs. Given that only 0.1% of a Macugen dose gets out of the eyeball and into general circulation, I was surprised that the FDA would consider the systemic safety of Macugen to be more than a formality.

There has always been some degree of lurking skepticism within the drug industry about administering a drug for AMD systemically. For instance, the iHub poster who probably knows more about AMD than anybody here (but unfortunately has gone MIA) is isolution. He was a big proponent of non-systemic drug delivery for AMD and said so assertively. (You can view isolution’s posts at http://www.investorshub.com/boards/profile.asp?User=27988 .)

Until recently, I dismissed the viewpoint of the anti-systemic advocates as petty prejudice against the unconventional. Now, I’m not so sure. GENR’s drastic reduction of the lowest tested Squalamine dose from 40mg in the Mexican trial to 10mg in the U.S. trials (first in the “207” study and then in the “208” study) suggests to me the iron hand of the FDA. Regards, Dew

P.S. In answer to your question about my shareholding, I reported having lightened up substantially in message #4495 (#msg-4454949).