We could arguably put this phase 1 trial down as a phase 2...It's increasingly looking that way.
It's an expanded phase 1 trial, keep this in mind.
It's also targeting a rare and unmet need in TCL cancers.
So when you have these levels of efficacy, in a expanded trial targeting these types of cancer...That's got blanket orphan status from FDA...I think we can confidently say next stop is registrational trial, skipping phase 2.
This means a massive saving in the tens of millions on a phase 2 trial.
This also likely means a much much smaller registrational trial than tradition...Due to it being unmet need of TCL...Likely a further saving in the tens of millions.
So we could have a drug that's quickly fast tracked to market by the FDA...This story could move at a rapid rate of knots.
Another important consideration...Not only is PTX-100 targeting an unmet need...But even if that need were suddenly met by competitors eg. A CAR-T program...It must be remembered that current CAR-T therapies are often $500k per dose...PTX-100 wouldn't come close and could be a very cost effective option for oncologist and patients without the deep pockets for more expensive options...The future looks very promising indeed.
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