Comparing Adstiladrin & TLT-Ruvidar...Comparing Adstiladrin and TLT-Ruvidar can give us a general idea of what is coming.
Adstiladrin...
Adstiladrin has a 23.5%CR at 450 days.
Restrictions...
1) Can't treat immune-deficient patients(that is a big restriction).
2) Has 289 major drugs interactions.
3) Need a treatment every 3 months(4 times a year).
TLT-Ruvidar...
TLT-Ruvidar has a 41%CR at 450 days.
Restrictions...
1) No restrictions whatsoever.
2) Is 100% safe.
3) ''One and done'' treatment.
Priority Review and BTD.
In this link...(provided by the FDA)
FDA Approves First Gene Therapy for the Treatment of High-Risk, Non-Muscle-Invasive Bladder Cancer Bottom of article.
It said '' The application(Adstiladrin) was granted '' Priority Review, Breakthrough Therapy, and Fast-Track designation.
Adstiladrin and Royalty Pharma ...Deal timeline.
In this link...
Royalty Pharma strikes $500M deal with Ferring on Adstiladrin '' Royalty Pharma paid US500 million for
5-8% of net sale of Adstiladrin in the US''.
Royalty Pharma US500 million deal was done
after the FDA BTD approval of Adstiladrin,
and
before the FDA BLA final approval of Adstiladrin.
(Note: TLT definively need the FDA BTD approval to kick-start the Big Pharma deal making process).
Priority Review, Breakthrough Therapy and US $500 million for a repeated treatment that has 289 major drug interactions, can't treat immune-deficient patients, and has a low 23.5%CR at 450 days.
-The above bodes very well for the FDA BTD approval of TLT-Ruvidar.
Here is the situation...
1) Because of the expiration of the 57million warrants(Aug2019 to Aug2024), TLT has a relatively low number of shares out,meaning...there is room for financing without to much dilution.
2) Adstiladrin FDA approval...
Why did the FDA gave Adstiladrin(a repeating treatment that has unimpressive data and a low CR%), Priority Review and BTD approval?
Answer...
Because BCG resistant NMIBC is an incurable disease for which there is no treatment, at the time Adstiladrin was the best treatment to whom the FDA could give BTD approval and Priority Review, in order to help those patients.
3)
As we speak, TLT-Ruvidar is by far the best treatment for incurable BCG resistant patients. 4)
For the very first time, the last projected date for the Pre-BTD submission was not pushed forward. To conclude...
Nobody know when BTD approval will be granted, but two things we know for sure...
1) FDA BTD approval is coming.
2) It is worth waiting for the FDA BTD approval of TLT-Ruvidar.
.