@ma420
I think you raise good points, and I somewhat agree with you. However, the Phase 1a/b is not optimised for evaluating Bisantrenes anti-cancer and cardioprotective effects. It is designed for dose escalation, safety, and tolerability of the new Bisantrene formulation and the combination (1a) and evaluating a signal of cardioprotection (1b). Of course, there are other things like m6A status, preliminary synergy data, etc. I am as confident as I could possibly be going into a clinical trial that Bisantrene will deliver on the intended outcomes from the phase 1a/b, and that these outcomes will provide substantial proof of a world first. The phase 2 use of the drug is where there will be more flexibility for RAC to use Bisantrene in an optimized way to most effectively synergise with Doxorubicin for the treatment of cancer while most effectively providing cardioprotection.
If you've watched my YouTube video, you'll know that the total monthly dose is the key factor I found that significantly impacts efficacy. Excluding the lead-in dose, I believe the phase 1b trial will likely only use a single dose of Bisantrene (D1) combined with Doxorubicin. In contrast, the phase 2 trial will have the flexibility to test various dosing schedules to optimize the treatment. For instance, if we use a 200 mg/m² dose of Bisantrene and increase the total monthly dose by administering it over more days (from Day 1 to Day 5), you'll notice a sharp rise in efficacy. I based this on my total monthly dose calculation and regression analysis to estimate the ORR (%). Additionally, the phase 2 trial will be expanded to test Bisantrene in different successful indications, which will either confirm or challenge the notion that Bisantrene should receive broad label approval for use wherever Doxorubicin or other anthracyclines are prescribed.
My understanding of the process for an acquisition is that there is a lot of communication that goes on between the company and the acquirer/s. The company and those advocating for the IP are very much involved in the communications. Speaking to the right people is more important than speaking. I do not think it is as simple as these organisations are waiting with their checkbook out hoping they can grab something at a deal - as you have suggested, the Magrolimab deal proves that they would want something safe to invest into for the duration of its patent life. The magrolimab deal also proves that they are prepared to pay big for a first-in-class drug with a lot of potential. Following a successful phase 1a/b, I believe RAC will likely focus their communications with a large U.S. biotechnology investment fund, which has the infrastructure and resources to accelerate this opportunity. While Bisantrene is an ideal biotech investment, I think decision-makers will wait until it’s proven. They’re likely more concerned with backing a sure winner, even if it means paying more later. Accelerated approval for CPACS means it can make money from day 1.
If you know your race horse is a winner, you don't put it up for sale after it has finished the medical and warm up. You show that it can win a race. The opposite is also true, where you probably wouldn't buy a race horse after it's finished the medical and a warm up, as you want to see it race.
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@ma420I think you raise good points, and I somewhat agree with...
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