So are you saying you would like to see those results at 10mg or that you don't think the 20/40mg results will be repeated?
I would certainly agree that the FDA has concerns and that the FDA is the reason behind the 10mg dosage testing. Why not test a lower dosage with Visudyne. I think it is certainly worth taking a look.
If the 10mg does not work I would say the FDA will still allow trials to proceed at higher dosage levels. If no one fell over dead, no severe side effects where seen from the 3 hr infusion in the NSCLC trials then the side effects are not bad enough to keep this drug from going forward if improvement in vision continues in the 20/40 mg testing. To think the FDA would not allow this drug to go forward if the 20/40mg results are equal to the results seen in the Mexico trials to me is absurd.
To date a few hundred patients have taken squal with dosages in excess of 100mg. I dont belive any of those patients had side effects that would prevent a patient from using this drug if it maintain or improved their vision.
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