RE: Strong Data Set for EUA28 Apr 2021 19:34
I am actually busy with other things today, but thank for the civil reply. I will only follow up on a couple of points.
Where there is confusion it is the company's job to clarify, clearly activ wanted to have more sites with sng001 and theybdidn't because of supply issues, I have to assume according to my logic whatever I assumed. But I can't clarify when all the facts are only known to the company and the activ people.
Also, in my view you got the commercial part wrong but also the essence of it. First of all if they don't get approval with current trials then they have nothing. Zero (meaning back to phase 2 for whatever).
Second, the commercial part makes more sense the way I describe it because not only it does not demand massive quantities but also for an emergency in particular the claim needs to be proportional to availability, no one is going to sign hymns to a miracle cure for everyone that is not going to be available for some time in relevant quantities. Apart from that, a drug that is targeted to a very specific population and it is very effcacious in that population, can easily have a high price and no one would argue against it. Those people with pre existing antibodies are less than 0.1% of the population, perhaps substantially less than that. However, they amount to about 10%, of patients with severe disease/ICU, that's a huge number, one that even if sng was manufacturing 100K treatments per month in January, they could still sell all of those worldwide. And a high price would make sense because it would be almost certain that these people would end up badly without it.
The same logic, but with everyone over 65 or over 50 with a comorbidity doesn't apply, just for the UK we are talking about many millions of people. Also, I don't beleive for a minute that efficacy will be 80% in the end in this broad populationv in every way that matters, in fact the release from hospital was not that impressive and not everything was statistically significant,. Another detail is that with such broad population and high price, it would be next to impossible to defend any IP that goes beyond their specific formulation, if it was the case that is super effective for all these people you would see many others approved bringing the prices down anyway. However, the FDA for example values A LOT highly targeted (indication) and at the same time highly effective drugs, to the point that it would give a company protection (reserve approval just for them for a few years) even if it was a 100% generic drug but one that in clinical development (that the company paid for) has shown to be highly effective in an unexpected indication for example. Add to that, that once the drug is approved, there would be no one to stop them from doing other trials for additional indications.