RE:RE:Back To The Data…Recap The FDA is well aware of the BCG shortage and the team of experts that will advice it are all urologists.
Given:
- that we would be the first non-immunotherapy drug that can deliver such results,
- that we are not in combo with BCG,
- that we are a standalone treatment,
- that we are a only 2 doses treatment,
- that we don’t have toxicity,
- that we could still be used in a combo,
- that we don’t discriminate among patients like immunotherapy drugs do
- that we could add more doses (e.g. 4 instead of 2 in a maintenance schedule)
- that we have other PDCs for other indications and that it could bring this PDT innovation to bedside
then it would be hard for them to pass over such an innovation, when they allowed chemo, Keytruda, BCG and many other toxic drugs, for something where patients don’t have many options.