Theralase Technologies Inc. V.TLT

Small correction to table

[DJDawg]

Corrected. 60% CR at 3m for Ruvidar. Thanks Eog.

Drug	FDA status	3 M CR	12 M CR	Route of administration	Number of treatments
Vicinium	FDA rejected	42%	17%	bladder instillation	36 instills per year
Keytrude	Approved	41%	19%	intravenous	every 3 weeks (indefinitely?)
Atezolizumab	Likely stalled	43%	20%	bladder instillation	every 3 week for 1 yr
Adstiladrin	Approved	53%	24%	bladder instillation	every 3 months for first year then after (?)
Oportuzumab monatox	not-approved	40%	17%	intravenous	15 treatment in a year approx but varies
n-803 + BCG	Approval deferred for now	55%	44%	bladder instillation	15 treatment in a year approx but varies
Valrubicin	Approved but not used (?)	21%	8%	bladder instillation	6 weekly as induction and that is all
Ruvidar	Phase 2 ongoing	60%	36%	bladder instillation	2 total

[wildbird1]

DJDawg thank's for the interesting numbers. Let's compare N-803+BCG & Ruvidar(TLD-1433) numbers.                            3M CR%            12M CR% N-803+BCG         55%                   44% Ruvidar 

[enriquesuave]

Could the FDA be considering to give AA for Ruvidar?  BTD is often given after much less data than we already have.  I'm not expecting AA right away, but who know?  As long as we get BTD and a path to AA.

[StevenBirch]

That sounds reasonable. With fewer treatments and superior safety numbers even similar CR numbers should be enough. We all keep saying that the numbers should continue to improve and eclipse ALL other treatments so maybe the 'delay' is waiting for that to be confirmed? The under treatment error continues to haunt us from a time standpoint and seems like the FDA wants it proven that was a

[Eoganacht]

I wonder what would happen if the FDA granted AA? Could there be one or more big pharma companies waiting in the wings who would be willing to help Theralase commercialize the treatment?

[patience69]

Hey Eog Have you been drinking Kool aid???  LOL

[skys1]

Agree Eoganacht, I made this same observation back in April when it appeared the FDA moved the goal post on TLT. The plan was to apply for BTD end of the 4th Q when they would have the needed stats. All of a sudden that plan was taken down. Why? It appeared the FDA had changed something.. The FDA has made dual approvals before in the case of immediate need, like the current need for a safe

[wildbird1]

enriquesuave...Interesting question... In this link... https://pharmdevgroup.com/fda-expedited-programs-explained/ Page 7...Under "Conclusion"... "Expedited programs(Fast Track, BTD, AA,Priority Review) frequently overlap and it is not unheard of for drug development programs to make simutaneous use of three or four of them". In short, Theralase could with sufficient data