RAC Primer, page-154

You might be thinking of this analysis.

https://hotcopper.com.au/posts/41536531/single

If you multiply the Phase transition probabilities you get the overall probability to progress from preclinical all the way to a marketed drug.

So any opportunity at preclinical stage has a 3.3% probability of going through to approval/marketing.

Any opportunity at Phase I stage has a 9.4% probability of going through to approval / marketing.

If an opportunity makes it into Phase II then safety has already been established in Phase I so Phase II is about establishing efficacy. From Phase II there is a 28.5% probability of going to approval / marketing.

Phase III is about trials in larger patient populations. These trials are very expensive to run. This is the Phase PAR are in now.



But with RAC and Bisantrene we know:

1. Bisantrene achieved an average 47% complete response across 6 historic trials. The result was Bisantrene being approved in France in 1990 but never marketed ( see note below )
   
2. Two French Girls were cured of AML due to combination therapy with Bisantrene
   https://www.raceoncology.com/wp-content/uploads/2020/08/PBC-060818-Bisantrene-Combo-Poster.pdf
3. Bisantrene still works. This was shown in the Israel trial (a single agent trial), except the patients were 3 times multiple refractory and they were only given a single course of treatment ( historically the patients received a consolidation course ).
   
4. RACE are essentially planning to use historic data in over 2,000 patients in the 1980s and 1990s plus data from the Israel trial in 2020 as background data to support an AML Phase II trial designed to achieve approval via the FDA 505(b)(2) pathway (my annotation added in orange to the figure below). This will allow RACE or a Big Pharma Buyer of RACE to pursue accelerated approval from a Phase II trial
   
   
   https://www.pharmacytimes.com/contr...b2-regulatory-pathway-for-new-drug-approvals-
   
   
   
   
5. For AML race has an Orphan Drug Designation. This means there is a 7 year commercial exclusivity period post-approval ( which is very attractive to big Pharma )
   
   https://www.fda.gov/drugs/developme...ently-asked-questions-patents-and-exclusivity
   
   
6. Once the drug is approved for AML, a big Pharma buyer could pursue off-label revenue for Breast Cancer (as oncologists will have data from the Breast Cancer trial planned this year).
   
   https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3538391/
   
   This results in oncologists gaining increased experience in the use of the drug for Breast Cancer and also informs the design of more formal approval trials by a Big Pharma buyer for Breast Cancer.

Note - Leukaemia was a very small market at this time because bone marrow transplants weren't as successful as they are now. American Home Products, the acquirer of American Cyanamid and its subsidiary Lederle Laboratories was more focused on the Multivitamin portfolio

So a drug that has gone all the way through Phase II to approval for AML (in France) and all the way through Phase III for Breast Cancer.

There are also (as explained above) aspects of the clinical strategy that mean RACE or a Big Pharma buyer could rapidly achieve marketing approval for AML with quite attractive add-on revenue from sales for Breast Cancer.

If you want to win a RACE, find a competitor that has made it through all stages of the RACE before.

If you want to bet on a RACE, find a competitor that has won a RACE before.​

See https://hotcopper.com.au/posts/51184808/single

This analysis is also important for perspective of phases of activity where M&A mostly occurs.

https://www.evaluate.com/vantage/articles/data-insights/ma/following-ma-money-phase-and-therapy-area