Disagree with your, but we all have a right to disagree..
It is very common during FDA’s review process to ask for clarification of some aspects of the submission. As you can see, the companies have not received any rejections...If it was not an approvable form, the FDA would have issued another CRL...This is a very good sign FDA considers IGXT and Redhill resubmission as an approvable form and as it common in the process to request follow up clarification.
To clarify even more, it is also common that if the resubmission is an approvable form, and as we can see it was evident this was a class 1 resubmission, becasue as for the FDA to find in the resubmission what else they needed to be clarified from the companies, they would have to have had a thorough review. Don't you think?
Once FDA questions have been clarified, FDA will issue a decision. I have seen this happen with many pharmas, and it is usually within weeks after the company’s providing their response.
GLTA
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