Replies to post #24039 on Cel Sci Corporation (CVM)

[Mogles]

Here is one example with the Cempra drug. Despite P3 efficacy, the FDA denied their NDA pending a further safety study. They also had concerns about manufacturing. Thankfully, MK doesn’t have any safety issues based on data to date and seems to have manufacturing solved. My point is that even if MK exceeds 10% OAS there are other risks to final approval. I’m not predicting FDA denial of our NDA. It’s just that with the length, complexity and historical issues with this trial CVM management needs to have everything else buttoned down to perfection to manage approval risks.


https://www.goodrx.com/blog/fda-denies-approval-for-new-antibiotic-solithromycin/