I don't believe the FDA would have done things this way if they didn't believe it could be resolved
That's a very reasonable interpretation of the situation. The FDA could have simply issued a thumbs down... they didn't. I don't think they're in the business of teasing the company or the investors.
The "C" in CRL is for "Complete". The FDA will not issue an action letter until the review is complete.
If the FDA sees some issue that will prevent the approval, they do not stop the review. The FDA has stated the review is not complete, so they can not issue the CRL yet.
Technically, the decision on a deficiency may be changed until the review is final. Bit that they decided to cancel the label discussions make it clear that they are certain the deficiencies will prevent approval.
The issue is what these deficiencies are, not if they exist.
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