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Replies to #6747 on Biotech Values
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rkcrules2001

01/13/05 2:26 PM

#6750 RE: DewDiligence #6747

<<It is impractical to consider retreatments more often than monthly, IMHO.>>

I'm not sure I would agree with this, at least from the patient's point of view. The small sample I have of people with severe AMD (one person!) would happily submit to weekly or bi-weekly IVs to improve his sight. And this very point may be why Levitt seems so interested now in 10mg and sub-q.

Obviously there may be safety and cost issues weighing against this frequency.

All your points are excellent food for thought, as always. Thanks for taking the time.




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winchem21

01/13/05 2:50 PM

#6751 RE: DewDiligence #6747

Here is a comparison of mean results from middle four 207 patients (dropping the highest and lowest) vs Mexico trials in terms of changes in letters of visual acuity using data from the posted slides.

Date  Mex  40mgs  40mgot  10mg 
Wk3 6.5 6.9 4.3 0.8
EOT 8.8 7.8 7.1 2.7
2Mon 6.9 2.8 2.9 -1.9
4Mon 5.7


40mg end of treatment 207 results appear to be comparable to Mexico trials. There clearly appears to be a dropoff in VA one month after treatment that was not seen during the Phase I/II after both 1 and 3 months in Mexico. The 10 mg results are poorer at all stages.

These preliminary results point to the possible need for weekly doses at 40 mg levels to maintain effective treatment.

wc21