Perhaps you mean Arzu Selen, not Sandra Kweder. Below is the final exchange in the transcripts. And yes, while she does voice a concern, she also mentions Macugen being a “huge” molecule with a 10 day half-life. I thought I read where squalamine has a 4-hour half life.
Regardless of all our speculation, the bottom line will be what data comes out of a large Ph.III trial, assuming we make it that far.
DR. DUNBAR: Are there any additional comments that the agency wishes to make?
DR. SELEN: Arzu Selen. One comment I would like to make is about the systemic bioavailability. I believe that there has been some discussion on this and, yes, indeed, there isn't a lot of drug circulating the systemic circulation. Nevertheless, given such a huge molecule, there is some bioavailability from intravitreal administration. Even though levels are low, it is still detectable. I guess I have to compliment the company on the quality and quantity of the pharmacokinetic data they have submitted. Based on this, it looks like the drug in humans a half-life somewhere around 10 days, and also ranges from 2-19 days in individuals. So, you know, there is considerable amount of drug remaining after a single dose. Nevertheless, the levels that you are looking at are at 0.3 mg and the dose was studied at 3 mg.
So, given that, it seems to me that there is a big margin there but, at the same time, there is also some evidence of non-linearity. So, taking all of that together, I think the part that comes into play is the clinical results and that was what Dr. Harris presented and that review did not show any big flags. But I think it is still an important thing to perhaps continue looking at and, you know, not just to overlook at this time anyway.
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