It's been clear that we were lucky in a way that such strong...

It's been clear that we were lucky in a way that such strong clinical activity occured in a rare blood cancer (namely TCL) and so early in the study of PTX100. It enabled Prescient to pursue trials requiring much fewer patients and requiring much less money to demonstrate the mechanism of action of this drug. The point being is that PTX100 could be proving to be a viable targeted therapy for inhibiting RAS mutation pathways in general (which occur in 30% of all cancers)! The more common (well know cancer types) naturally involve much larger trials which, consequently, cost more to undertake. It's obvious that if we can prove PTX100 to be viable as a monotherapy (safe and eficacious) then it will present hugely favourable as a targeted therapy in combination with other drugs.

Here are the basics about RAS mutations and inhibition of the RAS pathways:-






















PS: @hottod... yes, the heat is on but several things are in our favour here for acclerated approval:

1). PTX is having early discussions now with the regulators by the sounds of it
2). PTX100 is a Targeted Therapy
3). PTX100 is not a "me too" therapy
4). PTX100 is proving to have a 100% safety profile
5). PTX100 has broad potential and against solid tumours
6). RAS pathway inhibitors are one of the holy grails in oncology

The way I see it, the accelerated approval concept is great in theory but is proving not so great in practice... and those pitfalls do need fixing and are being addressed. Whether this is going to affect us majorly remains to be seen but our team are clearly cognisant to it and are dealing with it now and not waiting for it to present as a possible stumbling block.