In anticipation of the final PTX-100 1B expanded cohort readout....
I think it's important for investors to understand that regardless of any further responses or not, the data to date is already likely compelling enough for the FDA to award a pass straight to a registrational trail.
So if there is no new meat in the data, don't get your knickers in a twist & buy or sell without a proper understanding of the data. The market so often seems to do this before properly disseminating the data.
The safety profile is magnificent, the fact that we are having such strong responses in an unmet need is surely a green light straight to a registrational trial. The orphans drug status awarded to PTX-100 is a direct signal that the FDA are already looking to ways of supporting the drug through the development process.
I'm looking forward to the readout in December, but I'm even more looking forward to the results of the submission to the FDA regarding the next phase for PTX-100 in 1st quarter or early 2nd quarter of 2024.
Take your positions now and in the coming months in anticipation of a possible registrational trial, this will be the real fireworks imo.
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