Theralase Technologies Inc. V.TLT

Dosing Protocol

[Gman620]

Is there any protocol for continued dosing or is it two treatments and then you wait 450 days to see what happens?  Other drugs have a far greater dosing regimen. How was it decided to proceed with this protocol? It seems that additional treatments could improve results, couldn't it?

[DJDawg]

I don't know the history as well as others but I think they got excited and overly confident after the phase 1b patients who were 1 and done. Then later they added a second when reality came back round (1 and done is sweet but not a one sized fits all approach) I think they really wanted to avoid the multiple treatment approach of the other drugs. Once approved I'm sure that you would

[Oilminerdeluxe]

A second dose after 180 days, while the clock is ticking. Yes, it is believed by most here that additional doses could/should/would make results even better. Not sure why it was opted to go with only two treatments per patient, but I am sure others know better.

[Rumpl3StiltSkin]

1433 proved very destructive to cancer in vitro. 2 of the 6 in phase 1 have gone into remission from just one optimized treatment.  Yes, more is better considering how in-exact the NMIBC dosimetry can be. Which is why I think once in the clinic perhaps 3 or 4 optimized treatments will be the standard.  The trial design is to 'show off' what 1433 can do. It is about efficacy