Biotech Values

[mouton29]

There was one analyst question on sham and the answer didn't really say anything.

Here a homemade transcript of what I heard in that exchange, agree it's not particularly illuminating but still there is clearly a difference between what OCUL and EYPT are hearing or reporting:

1:28 Q I just wanted to follow up on some comments around use of sham and in the context of FDA draft guidance and whether there was a consideration of other potential mechanisms and and also did you consider perhaps an SPA as perhaps a competitor has.

A. so use of sham is interesting, you know Romero outlined all the interactions we've had with the FDA and at no point did they ever say to us we don't like the use of sham the way you have it designed. The draft guidelines, which I remind everybody are draft guidelines for public commentary, they're not things that have to be adhered to at this point, although our study adheres to every single one, when you read them there's nothing in there about masking, well designed trial, two of them. [SPA?] There’s no reason to think about an SPA because we're not a special protocol we are a vanilla non inferiority trial that's been run five times successfully in fact in some ways we're more vanilla than finisamab and hydrocylea because they were varying their treatment intervals we're not doing that we're in every six weeks we're going to be an every six month drug there's no reason to get an SPA, if if at some point an advantage pops up we might consider it but as of now we're not getting an SPA we don't need an SPA.