Theralase Technologies Inc. V.TLT

Patient 20

[Rumpl3StiltSkin]

So Yesterdays US patient #1 is also study 2s patient 20. I think we are officially on the FDA clock. Does anyone think TLT wll hesitate in submitting if the %s are good 1 year from now? Or is it 15 months from now? I think I remember reading this is a 15 month process?

Anyway, some time in late 2022, early 2023 TLT will hear back from the FDA regards Accelerated Approval. Personally, I think the %s will be good enough for them to feel comfortable submitting next June/July, assuming it is 12 months.

Until then we have more interim data that will come in on these first 20 + an additional ~20-30?
Covid 19 vax news could come as early as this year. GLP should be completed for 1433/Rutherrin so new Phase 1s can start next year. BTD will be granted some time early next year, IMO, which will make Accelerated Approval a given in 2023.

I think TLT is back on track, GLTA

[CancerSlayer]

  Just got back to the board & nice to see some interesting discussion... There are currently 4 expedited approval mechanisms for companies seeking full marketing approval.  All of these mechanisms allow for a shorter pre-market path towards FDA approval.  They include priority review, fast track, accelerated approval & BTD.  A company may apply/qualify for any or

[socksnblonds642]

The NR appears to be in line with FDA timelines for BTD. This is encouraging for sure. BTD applied for by end of phase two. Incidentally Fast Track can apparently be applied for at any time during the process. Both great opportunities for TLT to get treating patients sooner. "Breakthrough Therapy designation is requested by the drug company. If a sponsor has not requested breakthrough

[Rumpl3StiltSkin]

Yeah SnB, I think BTD is key for TLT. Especially if it shortens the overall time to Accelerated Approval for NMIBC. I think achieving BTD means Accelerated Approval is a given. And probably sooner.

[enriquesuave]

Since we don't have to to do a PH3 if data is good, then we can apply for BTD way before the end of PH2. Once it's clear that efficacy is shown to be high. IMO. On another note I was looking at Novocure a $20 Billion company which treats cancers such as GBM with electromagnetic fields and interrupts cancer cell division.  We will hopefully show high cancer destruction with an immune

[fredgoodwinson]

Novocure - looks like Royal Raymond Rife is alive and well and living in Haifa!

[Rumpl3StiltSkin]

Interesting, sure does sound a lot like Rife's tech. Wouldn't you love to know how true that RRR cancer story is??

[CancerSlayer]

X-ray/low-dose radiation activation + electromagnetic fields = WOW (Wipe Out Whatever)...what a combo therapy that would be for the more resistant cases.  May the force be with us : ).  Ultimately, patients need more effective options given the fact that each patient may respond a little differently to a given therapy.  Since BTD's inception almost a decade ago, the FDA has been