NorthWest Biotherapeutics Inc (NWBO)

[hankmanhub]

Bear, this is a great find, and I think it provides a full map for the applications to be made by NWBO to the FDA resulting from the PIII in GBM. It is very conservative and yet allows for a broad reach for approval for all solid cancers based on these PIII results.

First submit the standard BLA made for nGBM and rGBM based on the PIII done in GBM.
Then as per this provision NWBO should also submit a second BLA application for all solid cancers based on the same PIII in GBM as suggested in the FDA guidance "to seek a tissue agnostic indication in a supplemental application following initial drug approval in one or more specific cancer type(s)" with some results, as you suggest, from other solid cancer tests already done by NWBO as suggested in the FDA guidance "The supplemental
129 application for a tissue agnostic drug indication should include data in subjects with cancer types not studied in the initial tissue specific indication(s)"
I think this is great news and has the possibility to speed things up by many years to the $1000 per share future for NWBO if things go well. This is nothing less than an invitation by the FDA to follow this path.

Finally I would add an analogy to a prosecutor who has a very good case for murder in the second degree, but decides to try for a murder one trial which he risks an acquittal, and risks losing the murder two guilty finding. Here, simply filling directly a BLA for all solid cancers might risk losing approval due to the over-reach from the GBM trial. But by filing first just for GBM and then a second submission for all solid cancers on the same data avoids the risk of losing the GBM approval on its own, even if the larger ask is denied (which of course I hope will also be approved based on this guidance)