RE:RE:FDA and manufacturingANALIAS00 wrote:
They needed more time to look at the documents. They could have found things 2,3 weeks ago, kept reading the stuff, found more issues, and could now be writting the CRL at this time. I am still confident about approval, but I am sitting on the edge of my chair and waiting for the big relief !! Unfortunatly, CRL can come anytime until we get the approval. :(
If you read the documentation around FDA extensions then it emphasizes that an extension is only activated if the FDA believe there is a pathway to approval and that decision was made after they had had the new documentation for two weeks and had had a quick appraisal of it. In my mind all that favours approval but as you say the new submission could still be lacking in the detail.