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Replies to #4616 on Biotech Values
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biotplaya

11/07/04 5:24 AM

#4619 RE: DewDiligence #4616

>> my amateurish observation tells me 33% to 26% is not the way to go>> thank you for your response Dew. Yes, but is going from 33% to 26% 2 mos to 4mos something to get excited about? Will the same "downhill" results with the present testing be considered compelling? It seems to be going in the wrong direction, especially if compared to Lucentis 45%,34%. If anything, what's in GENRs favor? Thank you again Dew. I am long GENR and do not own any of the other AMD stocks. rgds..B

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krenjp

11/07/04 10:13 AM

#4622 RE: DewDiligence #4616


Dew, while I agree with you that having one patient losing vision in the 6 patients 10mg 207 trial is too bad, it is still too early to conclude. But I agree that this one patient is skewing the mean results negatively.

As far as I understand, the 10mg was added to the 207 trial and to the 211 trial to see how low the dose could go. From what I heard, with a 10mg, subcutaneous injection could have been possible. In the best of cases the one patient who suffered vision loss may have a particular condition; it would be worth knowing why this patient did not respond. But in any case, 1\6 patient is too early to conclude about the competitivity of sql. Note also that only 1 patient had positive vision improvement with 10mg.

The results of the Mexican PI-II trial were obtained with doses of 40mg and above. The next results will consider 20mg and 40mg; hopefully these will show comparable results.

As for the comparison with competitors, those are the numbers for competitors in PII that I had, per % of patients:
Macugen : 25%visual improvement - 71%stable vision
Lucentis: 26%visual improvement - 69%stable

Genaera Mexican PI-II: 33%visual improvement - 64%stable

Even with comparable results, sql could be used alone because it is safer, or in combination with visudyne because it acts on both eyes even without injection in both eyes. This would be an interesting option for physicians; and it lowers the risk for investors.

The fact that the drug is given in the arm rather than through the retina is in itself a strong comparative advantage given comparable data results. I have to disagree that only a drug with vision improvement can become a blockbuster; although we would all dream of seeing vision improvement for all patients.




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randychub

11/07/04 11:00 AM

#4624 RE: DewDiligence #4616

Dew "I want to see compelling data that replicate or nearly replicate the visual-acuity outcomes of the phase-1/2 study in Mexico. Regards"

Does this mean you want to see this compelling data in the 10mg dose or that you don't believe the 40 mg dose will work. In the past you have always defended the mexico trial data at 40mg.

R