Note that
all of the historic trials in AML achieved a strong result. Even the 23% if repeated in a slightly larger population potentially strong enough for an FDA approval.
The average complete response across all 6 trials is 47% and the drug was approved (registered) in France. I think my assessment of probability at 90% is fair.
Total number of patients in all these trials 111. Largest trial (40 patients) had a 50% complete response.
This is how the calculation works. I take the NPAT figure, multiply it by the clinical probability to arrive at a year 7 figure for annual NPAT. My spreadsheet ramps up sales from Year 1 to Year 7 and then flatlines from Year 7 to year 10. The 10 years of NPAT as will as the upfront development costs are the inputs to the NPV calculation.
I used a discount factor of 10% in the NPV calculation (because I have discounted NPAT by a clinical probability this is actually an rNPV calculation). The R/R AML indication was previously approved in France ... so maybe this discount factor should be wound back to perhaps 8%.
I used assumptions of 70% of AML patients becoming refractory (failing chemo) and 5% of this group then being treated with Bisantrene. I used a treatment cost based on Tibsovo at USD $333k for midpoint 900 patients against revenue USD $300M,
https://www.fiercebiotech.com/special-report/20-tibsovo
There are 43 trading days between now and the end of the quarter. We are expecting news on each of the 3 pillars by the end of the quarter.
So on Monday a 1 in 43 or 2.33% chance that we will get news on AML program.
On Tuesday a 1 in 42 or 2.38% chance we will be news on the AML program.
In parallel we are expecting news on Breast Cancer and FTO programs.
