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Replies to #670 on Biotech Values
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DewDiligence

12/19/03 10:26 AM

#674 RE: BullNBear52 #670

>> It doesn't look like they did well here. <<

Overall, the Macugen data are clearly a huge disappointment. However, after doing some DD, I’ve reversed my initial impression that the data are not good enough for FDA approval. I now think that Macugen is approvable, despite its marginal efficacy, because the modest benefit it provides is consistent across the three AMD subtypes (predominantly classic, minimally classic, and occult). Visudyne, by contrast, has shown efficacy in the minimally-classic and occult subtypes only when these subtypes are further narrowed according to lesion size and baseline visual acuity.

Although I now think Macugen is ultimately approvable, the FDA may want to see safety data out to two years before ruling. (That’s what I would ask for if I were an FDA reviewer.)