News Focus
News Focus
icon url

COR lurker

10/09/06 11:35 AM

#1352 RE: gfp927z #1350

From one of the press releases:

"The Company expects to have further toxicological information available toward the end of this year, after completion of three-month toxicology trials in both monkeys and rats. "

So, they have completed 3 month tox studies and have more tox results to come.

The FDA dosing restriction was not a surprise to Stoll and it shouldn't be a surprise to us. The FDA is just trying to be as conservative as possible, which is the same reason the hold was introduced in the first place.
icon url

bladerunner1717

10/09/06 11:46 AM

#1354 RE: gfp927z #1350

gfp,

One of the more confusing (for me) aspects of the PR is this statement from Stoll: "It is fortunate that the Company had the foresight to initiate the three-month toxicology trials early this summer, so that we can have further information from these studies available before year end 2006."

Why is Stoll trumpeting his "foresight." Weren't the three-month toxicology studies required by the FDA in order to get the clinical hold lifted? Or is Stoll referring to the fact that he had the "foresight" to initiate the studies so quickly?

I hope these questions are cleared up on the CC.


Bladerunner