Brilliant post Pharmagang - thanks for sharing this insight.
I've read the full FDA guidelines relevant to this (
https://www.fda.gov/media/99140/download) and the highlighted section below caught my attention:
Approach to Application Review. The standard approach for the review of NME NDAs and original BLAs is described in this section. However, the FDA review team and the applicant may discuss and reach mutual agreement on an alternative approach to the timing and nature of interactions and information exchange between the applicant and FDA, i.e., a Formal Communication Plan for the review of the NME NDA or original BLA. The Formal Communication Plan may include elements of the standard approach (e.g., a mid-cycle communication or a late-cycle meeting) as well as other interactions that sometimes occur during the review process (e.g., a meeting during the filing period to discuss the application, i.e., an “application orientation meeting”
. If appropriate, the Formal Communication Plan should specify those elements of the Program that FDA and the sponsor agree are unnecessary for the application under review. If the review team and the applicant anticipate developing a Formal Communication Plan, the elements of the plan should be discussed and agreed to at the pre-submission meeting (see Section I.B.1) and reflected in the meeting minutes. The Formal Communication Plan may be reviewed and amended at any time based on the progress of the review and the mutual agreement of the review team and the applicant. For example, the review team and the applicant may mutually agree at any time to cancel future specified interactions in the Program (e.g., the late-cycle meeting) that become unnecessary (e.g. because previous communications between the review team and the applicant are sufficient). Any amendments made to the Formal Communication Plan should be consistent with the goal of an efficient and timely first cycle review process and not impede the review team’s ability to conduct its review
It appears that the document provides guidelines, rather than hard and fast rules in relation to the review process and interactions between the FDA and the applicant during the review process.
Given that we are in 3rd cycle (3rd submission) with most sections of the BLA ticked off already and the review is limited to the additional items that are responsive to the August 23 CRL, I wouldn't completely rule out a chance that the FDA and MSB have a 'Formal Communication Plan' in place that is different to the standard plan - one that doesn't include all the types of usual meetings that are stated in this guideline.
You told the members of the forum once - make your own estimation and stand by it.
I still think we can get an early approval any day - even tomorrow is a possibility, but the likelihood of approval would, IMO, be decreasing in my world as we approach the PDFUA date. I'd be extremely worried if we don't have approval before end of December.
No news by the year end would indicate to me that something's still not ticked off by the FDA, and the cash runway will be extremely short then.
Between now and November is the most exciting, yet painful, time to wait.
(20min delay)