“I am very pleased to report these significant advances in our ZEN-3694 clinical program,” said Donald McCaffrey, Chief Executive Officer of Zenith. “It is clear that ZEN-3694 is safe and active, as shown by clinical data in multiple indications. The US FDA has given us positive feedback on potential development paths for our metastatic castration resistant prostate cancer program, including the potential for an accelerated approval. In the meantime, we continue to evaluate a number of scenarios for progressing ZEN-3694 towards registration-enabling studies.”
Would one be correct in saying we will know the FDA's position on this by the end of March for both Zen & RVX at the latest?How long can the FDA sit on their hands when they have something safe that could at least help & maybe save lives? Is it not immoral for them to drag this out to the max???
Didnt McCaffrey say 90 days?The release above was Dec 19th but i think he said the 90 days prior in regard to RVX?
glta