I feel the same, Hotdogs, but we have the following things that should work in our favour for registration approval of PTX-100:-
- Orpah Drug Designation (and not just for one indication)
- Another PR/CR added to our Efficacy Data
- Excellent Safety Profile
- Results are Based on a Monotherapy
- Recent Boxed Warnings Guidelines for CAR-T Therapies by the FDA
- Targeted Therapies are Less Complex and Costly to Develop
- Another T Cell Lymphoma Candidate Dropped Amid Safety and Efficacy Shortcomings
And, take a gander at these images of CTCL lesions in case our patient pics are not convincing enough that CTCL is a horrific disease:-
The PTX team and the FDA better get PTX-100 into a pivotal trial now! Who the hell would want to live with or die from a disease like this, FGS?
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I feel the same, Hotdogs, but we have the following things that...
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