The narrative may be like this:
The company submitted only one and same SAP to four RAs. As we have already known by now both UK and Germany have accepted the revised, reordered endpoints while the company might be still waiting for FDA's "buyin" of the revised endpoints and/or the approvals of rGBM in addition to the initial ndGBM based on the same current trial data before datalock. FDA might have been quiet on the revised, reordered endpoints, and the company may want a definite nod from FDA, ie. the buyin.
On 5 October, the company announced datalock which intentionally omitted a specific timeline for TLD, partly because FDA might have said to the company, "well, for all the requests of yours, let's first see the goods (the unblinded data)." These requests, besides the "buyin" of the revised, reordered endpoints could also include other requests such as fast track designation, accelerated approval, priority review designation, the approvals for rGBM in addition to the initial ndGBM (it may not be exact and specific as the above, just saying there may have been other requests besides the "buyin" of the revised SAP and/or the approval of rGBM).
Hence, there is no specific timeline in 5 October news release since the ball would have been first landed in FDA's court, and hence DI's comment, "we have been unable to ask CRO, the statisticians," because for quite some time after datalock, the company had still been blinded according to the agreement with FDA, while FDA and/or maybe the Steering Committee (SC on behalf of the company) have been first unblinded. And there have been Q&A going on between FDA and SC (on behalf of the company) and the statisticians.
FDA, bound by Covid-19 related issue has moved not as fast as we would expect, and its answers to the various requests from the company could only be forthcoming when it takes its time in today's Covid-19 environment.
But, I believe at this time, FDA has provided its initial comments to the company, the company has been since unblinded, and both the company and FDA have been trying to reach a consensus.
Until such a consensus is reached we may have to wait a bit longer. But when the time comes we may be pleasantly surprised with the results which, in addition to the long waited TLD, may also include an agreement for the company to submit BLAs for both ndGBM and rGBM based on the same trial data, let alone the acceptance of publication of the trial data in a first tier journal, etc.
The above may have been ongoing in parallel with company's preparations for TLD release and publication of the trial data. And I believe the delay of the 3rd quarterly report has also more or less something to do with the above conditions.
Although it can be any day now, in a sense I personally feel the longer the wait, the better the outcomes.
The bottom line is that with stellar data, whether the company has had FDA's "buyin" now or not really doesn't matter, despite potential delays or bumps on the road of approval, FDA will have to ultimately approve DCVax-L for GMB, because I cannot see any negative recommendations that could come out from any ADCOM called upon by FDA.
