RE:RE:Update!I don't think the question of a "narrower indication" would ever be discussed or even asked by the sponsor (after a no vote at the adcomm). TST is and will only go after their "plan A" indication.
But at the end of their review, the FDA still can decide to give a yes for a limited indication. And after reading their briefing document from the adcom meeting, I believe this is by far the most probable scenario. I would guess they will have the green light for "CIS-containing disease patients who have failed BCG therapy and can't or won't undergo cystectomy".
That would mean only a small limitation compared to what TST is hoping to get. No real limitation except for "papillary tumors only" patients. And those represents a minority...even more true now with the use of blue light cystoscopy...way more efficient to diagnosed CIS tumors that were missed before.
One thing is sure...if they get this FDA approval (for the indication above), TST is at the moment the most undervalued stock I know. A SP of 1.25 -1.5 U$ would be a minimum right after the approval. And that would still be a undervalued compared to other "one trick poney biotech" on the Nasdaq. A situation that only a reverse split would "fixed".
M80