Theralase Technologies Inc. V.TLT

The FDA might have no choice...

[wildbird1]

The FDA will give TLT treatment BTD(Breakthrough Designation) & AA (Accelerated Approval) only if the FDA see that there is a pressing need for TLT treatment.

Lert's see how the competition is doing...

1) BCG...
BCG is the standard of care, unfortunately there is a shortage of BCG.
https://discover.vumc.org/2021/02/bcg-shortages/will-persist/
As we speak regular patients are placed on a waiting list for BCG treatments, during that time there cancer could be progressing.

2) Keytruda...
Keytruda has a 41% CR at 12 months, unfortunately Keytruda has very bad side effects.
https://keytruda.com/side-effects/
(Quote) " Keytruda can cause your immune system to attack normal organs and sometimes become severe or life threatening and can lead to death".(End Of Quote)
Nothing more need to be said about Keytruda.

3) ImmunityBio...
ImmunityBio has a very good CR% of 71%/24 months(2022 numbers).
Unfortunately each patient need to start with 6 treatments in six weeks of BCG+N-803 and maintenence treatments of BCG+N-803 for up to 3 years.
That is a lot's of BCG treatment for just one patient.
Because of the shortage of BCG & the high number of BCG treatments needed for just one patient, the waiting list for the immunityBio patients could be very long, and by the time BCG become available the patient cancer could be progressing.

TLT treatment is a stand alone treatment.
The FDA might have no choice and see that TLT treatment doesn't need BCG, has no side effects and a CR% over 70%(could much higher for the optimised patients), all the above could be a very good reason for the FDA to give TLT treatment BTD & AA much faster than expected.

[Eoganacht]

Hi wildbird1 -  the competition is not doing nearly as well as you wrote in your post. I think TLD1433 will have a far higher CR rate than either Keytruda or Immunobio's drug. And as you have noted TLD1433 has a far better safety profile than Keytruda and requires far fewer treatments than either of them. I wrote some comments below in red.

[Yajne]

Thanks Eogan, great comments. IMO our time to emerge from the 'cloak of the unknown' and to be taken seriously by the 'oncology establishment', many of whom are betrothen to big pharma. Will be very interesting to observe their retreat from those previous 'engagements'.

[Rumpl3StiltSkin]

Eoga, I like your math. I think the main advantages for TLT are how safe it is, how few treatments and it doesn't need BCG!

[Rumpl3StiltSkin]

CR %s do have to be solid though. At least as good as Keytrudas. I think that is a fairly low bar.

[robertshaw]

Ours are far better than Merck 's Keytruda.

[wildbird1]

Eoganacht...Thank's for the clarification, TLT competion is in worst shape than I though. About BCG... I did mention BCG because according to experts, the BCG shortage could last 7-10 years, and for patients it could mean being placed on a very long waiting list while there cancer is progressing. This situation could prompt the FDA to start looking seriously for an alternative Standard Of

[Eoganacht]

Hi wildbird1 - If TLD1433 is approved for the treatment of BCG-unresponsive NMIBC doctors will have some discretion in using it "off-label", especially if it continues to exhibit such a superior safety profile. Roswell Park doctors do this regularly, treating all sorts of cancers with pdc's for cancers they were not approved for by the FDA. "FDA regulations allow doctors to

[CancerSlayer]

Eoganacht wrote: "Hi wildbird1 - If TLD1433 is approved for the treatment of BCG-unresponsive NMIBC doctors will have some discretion in using it "off-label", especially if it continues to exhibit such a superior safety profile. Roswell Park doctors do this regularly, treating all sorts of cancers with pdc's for cancers they were not