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The FDA is doing everything it legally can to get the DRTS treatment for GBM out to market.
They gave DTRS the FDA Breakthrough Device Designation, which accelerates patient access to the treatment by unlocking priority FDA reviews, hands-on agency collaboration and more.
They added DRTS to the FDA TAP Program (Total Product Life Cycle Advisory), providing early, frequent, and strategic engagement with FDA advisors as well as patients, potential payers, providers and more.
The FDA also holds quarterly meetings with DRTS on top of all the special and regular communications.
The FDA are doing everything they can and using every fast track possible to get the DRTS treatment approved for GBM.
And it’s going great. It’s going full speed ahead.
But why is the FDA doing all of this? Because of the DRTS results and the hope they bring to millions (maybe billions? we’re all in this together) worldwide.
GBM is the most common and most aggressive brain cancer. The prognosis is poor and is sadly measured in months. To date there isn’t really a long term treatment for it, because in most cases (aside from the side effects) even if it’s treated it relatively quickly comes back.
The DRTS treatment is a solid tumor agnostic physics based treatment, it delivers alpha particles (radiation) straight into the tumor, it destroys the cancer cells from within causing a double strand break in the DNA while sparing healthy tissue.
In other words, it’s a treatment that has proven to be both safe and effective against any solid tumor, including the most high unmet needs in sensitive locations, like Pancreas, Lungs, Breast, Prostate, Liver, H&N… and GBM.
And the most recent DRTS results surprised even the FDA, who specially requested to see for themselves.
DRTS has treated three recurring GBM patients of different profiles and GBM types, and achieved the unheard of 100% local control, with two complete responses (the cancer completely disappeared) and the third achieving more than 30% shrinkage of the tumor (unbelievable in and of itself).
In the case of the first patient for example, the doctor said his life expectancy was zero, he already had multiple recurrences, tried multiple different treatments including three different clinical trials, there was nothing left to do and his days couldn’t even be numbered, he had nothing left.
Then came DRTS, he was treated with it in his brain in December last year, a one time single session treatment from which he went home on his own power walking out of the hospital the next day, and here we are six months later, half a year and he’s still clean, went back to living his life with his regular activities and even traveling.
The amazed FDA wasted no time, they immediately approved the DRTS trial to complete with 10 patients and approved additional clinical sites.
And DRTS hasn’t wasted any time either, as we’ve learned (only days after the FDA approval) that patients #4 and #5 were already recruited and scheduled to be treated!
And DRTS isn’t planning to waste any time moving forward, as the CMO Dr. Den already stated they will be using the data from this trial to submit for a Pivotal trial, which he believes (and he is not only experienced but also in constant communication with the FDA) will be a rather small trial and will be enough to support submission for Premarket Approval (aka commercialization).
To bring it home, there is a potential treatment for GBM going full speed ahead, with the FDA’s full backing and encouragement, with all the funding needed, an experienced team, and no time to waste.
NFA and DYOR, but aside from this being worth celebrating from a moral standpoint, you could be cheering as part of the team by investing at sub 1B market cap with the potential of 10B+ if and when DRTS will commercialize GBM, which looks to be sooner than the market expects, and being only one of the many indications DRTS is planning to commercialize.