The FDA are good people. They are all about getting treatment to patients as soon as they can, as long as its safe. Now that has over simplified it, but that is what they are about.
PTX100 has proven, that as a mono therapy, it can extend the life of those patients where the standard treatment has not worked. it has good safety. Thats all we need. CRs are awesome. but you dont need that to get approval. And remember, the patients that we have had in trial so far as those that have relapsed disease. Thatbis, those where the SOC has already failed them, and they have no other option.
For the approval trial, I would expect ( me guessing) that the drug would be administered earlier in treatment. So we could potentially get even better results.
Nothing is a surebthing until it is. But the basket study, and the phase 1 trial tend to point towards a drug that works as expected.
If we can keep replicating the results we have now we will get approval.
The FDA are good people. They are all about getting treatment to...
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