Monday, February 23, 2009 8:48:06 AM
I'm saying they met all of the requests from the FDA....
...in order to receive approval of Genasense for the treatment of CLL, as specified by the FDA. The wording from the FDA was "not approvable in its current form" reads like it was an issue that could be addressed. Genta leadership met with FDA leadership to discuss the issue(s), then submitted the appeal.
The FDA has a 30 day response performance metric for submitted appeals. If it was a slam dunk NO, we would've certainly heard the response by now. The appeal was submitted in mid-December 2008. We're now at the end of February.
A company with late stage anticancer drugs in their pipeline like Genta and everything on the horizon for 2009...this is a STEAL at one penny. Are you kidding me?
...in order to receive approval of Genasense for the treatment of CLL, as specified by the FDA. The wording from the FDA was "not approvable in its current form" reads like it was an issue that could be addressed. Genta leadership met with FDA leadership to discuss the issue(s), then submitted the appeal.
The FDA has a 30 day response performance metric for submitted appeals. If it was a slam dunk NO, we would've certainly heard the response by now. The appeal was submitted in mid-December 2008. We're now at the end of February.
A company with late stage anticancer drugs in their pipeline like Genta and everything on the horizon for 2009...this is a STEAL at one penny. Are you kidding me?
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