RE:RE:well just maybeEoganacht wrote: That makes sense. Of course any prospective jv partner will know that Theralase needs help to move forward but the company can't be seen as desperate to accept any deal just to keep the lights on. It would be good to have been granted BTD and possibly even have started another trial before serious negotiations. Ideally Theralase will have several deals to choose from.
It's good to remember that halfway through the trial Ruvidar PDT is shaping up to be the best BCG-unresponsive NMIBC monotherapy available - in terms of efficacy, durability of response, safety, tolerability, ease of use, and number of treatments. In addition to all these selling points, the actual decision-makers and treatment administrators - urologists - will have their own reasons to prefer to use this treatment. As Dr. Kulkarni said to Dr. Kamat:
"...one of the advantages here is it is a urologist run therapy. Urologists are comfortable going to the OR and treating patients cystoscopically or endoscopically."
Ruvidar PDT for BCG-unresponsive NMIBC is not like Keytruda, which has already been approved for this cancer indication. Keytruda has low efficacy and serious side effects and urological oncologists prefer not to use it for NMIBC.
It makes sense for a big pharma to want in on Theralase's NMIBC treatment, but the timing isn't quite here yet.
m8magic wrote: this raise was needed to strenghten our negotiating position with our JV partner to be announced....Roger did indicate you can't negotiate with hat in hand...our future partner now knows we can possibly do it all without them so their demands will be less greedy..jmo
Yes, the timing is the billion dollar question and we must remember: the longer commercial advancement of Ruvidar is delayed, the longer Merck (Keytruda) can retain it's roughly $1.4B annual global sales as the approved standard of care, which begs the question of the effectiveness of the fast track designation and all these ongoing delays with BTD submission.
Was this an issue of Theralase not having enough funds to staff the right execs and advisory members offering much needed relevant FDA expertise? Or has this been an intentional slow walk by the FDA advisory panel by "sin of omission", i.e. leaving out a crucial detail here or there only to circle back and say, "wait, now we need this additional requirement to be met".
I hate to play conspiracy theorist and we must concede Theralase management has dropped the ball a number of times, but it took Merck's keytruda almost 7 years to get into its peak sales earnings stride and Ruvidar is likely going to be the gold standard based on the data we have to date, so Merck, with I'm sure many very "good friends" at the FDA stands to lose a lot. At the very least, the fast track designation has not at all lived up to expectations, which would be a streamlined communication process with clear expectations and targets.