RE:RE:RE:RE:RE:RE:Been here a while lurking Indeed. Excellent post Gebremeskel.
TLT went into many tiny details to increase chances of success, minimize costs, adjust asap, think outside the box, solve issues, etc ... Like these:
- chosing a molecule (TLD-1433) that works both in oncology and anti-virus
- chosing a molecule (TLD-1433) that, when mixed with transferrin, becomes even more potent, without having more side-effects than TLD1433 alone but that can be used against more agressive and more challenging indications like NSCLC and GBM
- chosing a route of delivery (intravesical versus systemic) that would favor safety
- chosing an indication that would not require a long and costly Ph. 3 (5y 1B$US+) but rather only a pivotal Ph. 2
- investing in R&D to protect bladder wall
- investing in a dosimetry software that works for more than just one indication
- automated the full process so it can fit NMIBC and MIBC
- working with top minds (Prof. McFarland, Dr. Rueck, Prof. Lilge, IBM, Intel, etc ...),
- worked with academic institutions (UHN) to lower R&D costs
- never cut corners
- having a Ph. 1b that ended early (because of huge safety profile)
- obtained FDA FastTrack designation
- took time to optimize processes twice
- Phase 1b: between p#4 and p#5 that ended up in having p#5-6 being cancer free for more than 2y
- Phase 2b: after p#12
- candidate to Breakthrough (that would confirm us as a next SOC)
- candidate to Accelerated Approval (that could save us 30 months of delays in potential revenues)
- jump on the COVID-19 opportunity to test TLD1433 against COVID-19 (and other enveloped viruses)
- signed a SRA (Sponsored Research Agreement) with Univ. of Manitoba aginst COVID-19
- obtained PHAC-NML's interest to push our TLD1433 to complete the last preclinical tests
- survice to a 1.5y lost of patient recruitment that affected its ability to enroll and treat patients during the COVID-19 crisis
And we would be poorly managed? Lolll This comment must be coming from a libertarian that lacks judgement and cannot appreciate all that's been done, that takes things for granted and that probably doesn't even know how to compete.
________________
gebremeskel - (11/9/2022 4:18:02 PM)
RE:RE:RE:RE:RE:Been here a while lurking
We're all hoping that. Shareholders are hoping that and everyone at Theralase is hoping that. Theralase will stick to the Q4 submission milestone if they possibly can because it is in their interest to do so. It's in their interest to get BTD. It's in their interest to get FDA approval to commercialize a treatment for bladder cancer. And it's in their interest to accomplish this as soon as humanly possible.The delays so far have been beyond anyone's control.
The science is the easy part, making things happen in the real world is the hard part. Against all odds it looks like Theralase may pull this off. There are reasons behind the current communication situation and you would understand this if you were really a long and had been paying attention.
emeskel - (11/9/2022 4:18:02 PM)
RE:RE:RE:RE:RE:Been here a while lurking
We're all hoping that. Shareholders are hoping that and everyone at Theralase is hoping that. Theralase will stick to the Q4 submission milestone if they possibly can because it is in their interest to do so. It's in their interest to get BTD. It's in their interest to get FDA approval to commercialize a treatment for bladder cancer. And it's in their interest to accomplish this as soon as humanly possible.The delays so far have been beyond anyone's control.
The science is the easy part, making things happen in the real world is the hard part. Against all odds it looks like Theralase may pull this off. There are reasons behind the current communication situation and you would understand this if you were really a long and had been paying attention.