Can DRTS submit for FDA approval of their GBM treatment as early as this coming year?

Alpha Tau (NASDAQ: DRTS) has announced groundbreaking news. They have achieved complete response in recurring GBM, the most common and aggressive brain cancer.

If you listen closely to the conference call, you’ll notice the company is already looking forward, and the FDA is on board.

Usually the approval process for biotech companies could take years, but in this case we might be seeing record times to get this life saving treatment to patients.

The current standard of care for this dreadful disease is that there’s no standard of care, survival is sadly measured in months, and until now there has been no real breakthrough.

And here comes DRTS, not only demonstrating the treatment is safe, not only being able to show efficacy, but achieving the unheard of continues complete response. The brain is clean and symptom free on follow up.

So what’s next? They complete the current study by treating the remaining seven patients, and share the results after ~3 months, which should allow them to request a pivotal trial before EOY.

The important yet lesser known facts:

A. If the results hold up (there’s no reason to believe they won’t), the FDA is expected to approve the pivotal trial.

B. If the results hold up they won’t be needing many patients in the pivotal trial.

C. They won’t have any recruitment issues, there are many more patients willing (wanting, asking) to participate in the trial than the actual number they will need.

D. The survival rate (and therefore follow up requirement) is measured in months.

E. They have FDA Breakthrough Device Designation & FDA TAP Program for this indication, which is like a fast track and constant discussion with the FDA and even advice through the whole process from planning the trials all the way to bringing it to market.

F. There really are no other options for this fatal disease.

It might seem ambitious, but doing the math while understanding the necessity, it is realistic (not without the biotech risks of needing results to hold up and cash and the exact timeline might be off) to think DRTS will compete everything needed this coming year and it will be in the hands of the FDA (who wants this to happen very much) to approve the treatment for commercial use.

Now the moral of the story is obvious, this news is very exciting from a humanity standpoint. But why am I sharing this conclusion in a Stocks sub? Because if (and when) this treatment is approved for GBM, that alone would push the share price north of 100$.

I personally have a large long position, but after yesterday’s news this (much more than GBM) treatment for GBM now has a timer, and every day that goes by gets the DRTS stock that’s on sale under double digits closer to triple digits. And if all this will happen before EOY next year, you could count on the market to start pricing it in way before then.

NFA and DYOR, but GBM can’t wait so nor should you.