My rough math with assumptions The total BCG resistant NMIBC opportunity is estimated at $1.1B to $5B annually (corporate presentation). Assume 300M shares (options and warrants inclusive) and assume a conservative opportunity of $1.8B, give or take, after BTD approval. I'm assuming the other 60% of the available max of $5B will be split between newly-approved or in-process trials. Then apply a conservative valuation of 1X of sales. That would put the stock price in the $6-$7 range, if my math is right. That's a nearly 3000% rise from current levels, over a period of UNKNOWN time. All with one indication and without considering other opportunities as a combo drug with immunotherapy and gene therapy. The experts here can hopefully fix any major gaps in math.
So the big need is for the clinical data to be so undisputably good that this treatment becomes the de-facto for BCG resistant NMIBC. To be considered for more upstream use (before trying BCG - as a standalone, or in combination with already approved drugs like BCG or Keytruda) might take a while, give how cautious the FDA is of late. IMHO.