RE: SO will be out today/morning29 Mar 2022 10:52
@Chris - Clinical trials are very complex and must be designed properly to have power to predict the responses beyond reasonable doubt. One complexity with microbiome drugs is that we don't know what the gut-microbiome composition of these patients was prior to 518 or before prior lines of ICI.. so, when we see response to 518, there is always one factor that has not been covered with enough power, which is that somehow the trail has biased the selection of patients with favourable microbiome for ICI/518 treatment. This is something FDA will ask... This is where 4D must come up with power calculations to arrive at a target number of patients for phase 3, that will cover this factor. If we then see 20% response in that cohort of 120-180 patients, then this can be extrapolated, with certain degree of error, to all the RCC refractory patients.
How do you think Merck and 4D will arrive at a valuation for 518? They can't pluck the number from thin air, right? You make estimations of in how many patients it will work and how much revenue it will add per year and do that 5/6/7/8/10 year period and a proportion of that total sales revenue will be offered now to sell the drug.. If it will add $10bn, we will be offered $1bn..
$7.5m will just cover costs for 3 months max... gives us time to raise money when we have achieved the right valuation.. As I said, Phase 3 approved for RCC with an indication from FDA that if mid-trial certain thresholds are met, they will consider approval for emergency use will push the valuation north of $700m.. this could happen in H2, we can raise money then for a phase3, Asthma and Parkinson's trials. Or as we would have de risked the drug by now, a mix of raise and parter sponsored trails..