RE:RE:RE:RE:RE:Question for bencroLaserStock29 wrote: Good posts Medically we find out multi treat. Ph2. Financially. Preclin gbm 50m+ Preclin lung 50m+ Phase 1b Nmibc 160m+ There has to be a quantitative $ difference between mice rats and humans Outsized success like weve had allows fda to give us cures act provisions. Also discover and develop deal that pays us for work already accomplished and pays for phase 2 + bringing online phase 1 gbm and lung w tld 1633 as the new discover drug. 25m front + 250m back + bonuses for milestones hit. Valuation for work already complete with destruct rares rates 95% + higher for preclin and basically 99% in phase 1. $2.15+ Patient 9 gets treated. I want fair market value.
enriquesuave wrote: Just to compare with other trials. EBIO and their Vicinium drug saw recurrence in 60% after 3 months. Thus it only had a 40% efficacy at 3 months after multiple weekly treatments. With just one treatment our PDT so far produced 100% no recurrence at 3 months. Conclusion we know it works very well and will likely require multiple treatments in order to produce an immune response which will further delay recurrence and more importantly delay Progression. Bionic is just trying to cloud your judgement. We will still only find out after PH2
bionicjoe wrote: enriquesuave wrote: I beleive that this question was already addressed here. We won't really know until the end of trial and really only after PH2. IMHO. For sure it's logical that Higher dose should give at least the same or better results. As stated by company, recurrence seen after 6 months was very probably due to seeding from upper tract. Failed BCG cases show recurrence at 3 months Mark, so the low dose most probably acheieved 100% tumor destruction, if not undestroyed micro metastasis would have developed into visible tumors after 3 months. That was not the case. However no matter what the cause of recurrence, PDT generated immune responses usually occur after 2-3 sessions, especially since TURBT was done prior here lessening the immune stimulation after PDT. An immune response should prevent recurrence from seeding . Logically, non UUTUC cases may show long term recurrence free patients after only one treatment, possibly. IMHO. Time will tell, but we know it works extremely well so far.
goregil wrote: My question is will the higher dose be more effective than the low dose .will the high dose have a advantage over the low dose.will it stop cancer cells from returning If the low dose kills all treated cancer cells can a high dose do any better if so how ,I know this is a tough question Bencro but give it your best shot answer it
The medical team conducting the trial never concluded that the low dose achieved 100% tumor destruction at 3 months. In fact, it's fair to say all the speculation reported in the Roger White Nov 8th PR update is open to question now that we know better from the OSC investigation how RW had a habit of making the truth fit his agenda.
" Latent effect of 3-6 months reported on follow-up biopsies "
That's a direct quote from the MOFFITT Cancer Center's discussion of BCG. Let me save everyone the trouble of looking up the meaning of latent effect:
present but not visible, apparent, or actualized; existing as potential: latent ability. 2. Pathology. (of an infectious agent or disease) remaining in an inactive or hidden phase; dormant. The cancer can still be there but not visible for up to 6 months. That's why I keep harping on the importance of 6, 12 month and even further followups to get a true idea if the science is working. Forget the 90 day cancer-free pitch. Have you seen a world wide response from the medical community that TLT has achieved any breakthrough in cancer with their 90 day hypothesis?
The question is a valid one and the replies shouldn't be shrouded in attempts to cloud the facts. The way things stand now the first 3 patients all had cancer recur at 6 months when given the half dose of TLD-1433. If you double the dose will it make a difference to the 6 month recurrence results? Answer....we don't know because the company has chosen to change their disclosure procedure for the second phase of the study and not release that information to the public. My guess is they don't want a repeat of the sp crash following the Nov 8 PR. By grouping the last 6 patients in the final report they can then claim victory if a couple of patients didn't experience cancer recurrence. And let's stop kidding ourselves, it is all about efficacy. A secondary factor in not releasing individual 6 month results might be to secure refinancing money first just on the anticipation of better results from the full dose.
Safety & tolerability is without a doubt the main goal of this trial. I don't think anybody doubts they will achieve it. I think the reason they chose a 1B trial over a 1A is so they can shop the efficacy results around to help pay for a continuation of the study to a phase 2. Safety & tolerability will get you approval to hold a phase 2 trial but good exploratory efficacy results will allow you to fund the trial. Without compelling efficacy numbers the capital markets will be hesitant to spend $15 million and then worry they will get the same efficacy results.
https://moffitt.org/media/5451/scott-gilbert-md.pdf
All of you guys ' great post made bisexualblowjobjoe look like a fu(king stink douchebag ,a dogshit churning stick. Thanks for all of the science DD. Much appreciated.