Yes, first they have to get the safety data out of
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Posted On: 06/08/2019 12:06:37 PM
Re: ClosetInvestor #3865
Yes, first they have to get the safety data out of the way, which will take a little time, then yes they will need data for so many patients. I have not researched how many the FDA requires on average. NP said if they get good numbers on 5 they will apply for breakthrough designation. But after this gets started and is past the safety data, it can happen very quickly.
Also if TNBC numbers are good and leronlimab is approved for combo, it is not uncommon for off-label in cancer--I believe 40% of prescribed drugs in oncology is off-label. It is usually though using one cancer drug for another cancer, but I posted here people had insurance approve maraviroc for cancer treatment based on their phase 2 results.
If leronlimab is approved for tnbc, then the off-label use will skyrocket in other cancers in my opinion, even before moa is approved.
Also if TNBC numbers are good and leronlimab is approved for combo, it is not uncommon for off-label in cancer--I believe 40% of prescribed drugs in oncology is off-label. It is usually though using one cancer drug for another cancer, but I posted here people had insurance approve maraviroc for cancer treatment based on their phase 2 results.
If leronlimab is approved for tnbc, then the off-label use will skyrocket in other cancers in my opinion, even before moa is approved.
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