Theralase Technologies Inc. V.TLT

Burning Questions...

[islandphile]

If Ligne et al knew which dosimetry worked for Phase I patients 5 & 6 to create a CR, was the dosimetry changed in Phase II for the 8 current (or 12) patients?

If it wasn't changed, then who incorrectly administered the incorrect dose? How could this happen, was no one supervising and verifying?

If dosimetry was changed, who is responsible for this change? Was this done collabratively or did someone go rogue? Or negligence?

Does the company still have sufficient cash reserves to complete Phase II without doing another private placement?

Was Theralase sabotaged?

Some heads should roll over this.

[Johnandrose22]

Thank you for your post...they coincide with my own completely.

[2b7f6fab]

Couple years ago during Ph1 I and Dr Lilge came out with his laser dosimetry device and subsequently gave the patents to TLT did you ever wonder why didn't someone from Theralase come up with this device?  What are we paying the researchers at Theralase?  Now researchers at RPCI have developed their own device and using Dr SM compound are proposing to use it for NSCLC.  I find

[2b7f6fab]

And there's some banana brains character on the other message board who's wondering why any researchers would want to be associated with theralase anymore.  Let me just tell you up front buddy it wasn't an MBA or CPA who screwed up this trial.  It was associated scientist/doctors who did this FU. I am wondering how the associated scientist/doctors feel about what is going on

[Quattro74]

Is this really a FU by the Docs/Research clinicians? I mean the phase 1 was only 6 patients. There is so much variability in patients for the DFOC here as designed. They will see even more variability, learn more how to 'fine tune' the DFOC as they move forward. To me, as I read it, the undertreatment was with the light, not the PDC 1433 dose???

[2b7f6fab]

It was both light and dose but mainly dose.  You tryinng to make excuse for AM?  That lack of communications is laid on the researchers at Theralase.

[Quattro74]

Ok, I stand corrected. I do think these Docs have time/talent to clean this up. We'll see how well their adjustments work for treatment two and also, once sites commence, for new enrollees.

[2b7f6fab]

AM should resign, RW should retire and the CEO should layoff everyone from the laser and research divisions.   Let other organizations that know about lung and brain cancer do the requisite research.  Anymore it seems like Theralase holding TLT1433 is like putting a gold ring in a pigs snout.

[Hempdoc]

  Hey Quattro....the total therapeutic dose of TLD1433 is dependent on bladder surface area (0.7 mg per square cm).  If you underestimate the area, you end up providing a sub-therapeutic dose.   Determining device treatment time based on a single variable (bladder volume) makes sense as long as the established pretreatment volume is effectively duplicated during the actual

[Bunge]

Can you take over the trial Hemp? Pretty please. ;)

[Hempdoc]

Lol...I like to keep my creative talents outside of the lab & in the....lost my train of thought.   At least we own the golden key, TLD1433, & have added that last spark plug to get this protocol running on all cylinders (though belatedly).  Results should get a boost moving forward & we still have a good chance that 25ish patients treated will get us to a BTD or

[Quattro74]

Hey Doc, Thanks. That is a good explanation of this. I really hope they have figured this out, we'll see.

[tomchoco]

Hemp- who would you blame for the misdiagnosis or is this treatment a trial by error and just needs some fine tuning. Do the results set us back time wise in a race to see who captures the prize for treating bladder cancer. Would you see us moving together in a partnership with someone else who can advance this at a better clip and get it done right.

[Hempdoc]

  Hey Tom...I was answering Bunge in my last post.  I don't directly blame the PIs or Theralase mgmt.  I had just expected better guidance from our advisory board who should have (or may have) raised these concerns & corrected them.  Frankly, I thought the FDA pre-IND meeting had given Theralase standard guidance on the eligibility criteria or appropriateness for a

[Quattro74]

Yeah Tom, If Doc is right about them figuring out this new calculation for the DFOC, then we are looking at crazy good % numbers as NMIBC study 2 continues. I expect they will still remain independent and get Acclerated Approval for this indication. Partnerships welcome for others.

[tomchoco]

Thanks for the replies. It would be nice if the company could do a CC with investors to clarify what happened and give reassurances to investors that things are now on the right track. The communication skills are lacking. I understand they have no one handling IR now as communicayion is now being directed to senior staff members. Not sure who you email for questions.

[Hankerchief]

  Good point.  Could also use Twitter.  Not sure why they can't make the effort to do that. 

[O12009]

I have a very hard time believing that PMH who was in charge of the Phase 1 trial and knew the procedure would make the dosage and treatment mistakes that is being claimed by TLT , something is rotten. If you were PMH Would you not use the same team who done the first trial and treated patient 5 and 6.