PTX Media related, page-1035

Thanks Blue.

Re PTX100 clinical data, SYC states:"We will be putting out an update on this very shortly... it'll likely be next week or shortly thereafter."

Fwiw, my take on the briefing is that PTX-100 has every chance of achieving accelerated approval... or, at the very least, our team are going to be giving it every chance of achieving accelerated approval. Its not just the efficacy and safety that puts PTX100 in good stead. The drugs on the market only provide a few extra months of life and come with bloody awful side effects causing hospitalisation. From 18:35, Steven addresses the context in which (for me) makes PTX100 a potential standout.

In fact, the company has already commenced compiling what is a comprehensive CMC data package (Chemistry Manufacturing Controls) which comprises of both clinical and supporting data... in anticipation of success.

Steven states that "If we get Acelerated Approval [for PTX100], it will be huuuuge... huge, huge, huge!"

He makes an off-the-cuff statement that its possible we could commence an accelerated trial this year. There seems to be some indecision as to whether to progress PTCL or CTCL but that a single trial for both is a consideration and a possiblity (from what I recall). I don't know what other posters think about the (good) issue we have with patients living beyond the target duration which keeps the trial from concluding, though...?

"We are running future plans in parallel trying to anticipate what's going to happen" is what he states. Hopefully, we can proceed to the next stage regardless of the trial status if the data warrants approval.

The last readout for PTX100 was in late October, therefore, its possible that several patients will have lived beyond the SOC survival duration and even our Target by now.