Biotech Values

[biotech jim]

Those slides simply show dose responses, demonstraing there is a solid dose response.

As I said in my post responding to the reviewer's criticism, there were poooled data from Ph3 data that spoke to the efficacy issue and this data will likely be broken out in different dose groups to speak to the issue of 75mg vs 150 mg differential efficacy. Since I did not see the NDA package submitted to the agency, of course I am not sure that the data was broken out into the two dose groups. But it is obvious to me that it would/could/should have been. If not, such data has been put into a power point since the FDA breifing document was received by the sponsors.

Seems to me, that to fully satisfy the reviewer, CV outcomes in both dose groups would be needed and that was not practical. The FDA clearly weighed in on the CV outcomes trial design, and there exists only the 150mg dose group compared to PBO.

https://clinicaltrials.gov/ct2/show/NCT01663402

http://newsroom.regeneron.com/releasedetail.cfm?ReleaseID=901604

http://www.ahjonline.com/article/S0002-8703(14)00494-3/pdf