RE: Can someone clarify...12 May 2021 13:27
The company's USP was that we can send you an easy-to-administer early home treatment. They now had to make a u-turn on that USP, because they found out the drug is better off administered later in the course of the illness (an idea that initially took them by surprise when the hospital arm results came in). If there's not enough patients with significant breathlessness in Activ-2, then it will fail to collect any significant data, just like the HT did.
If there's not enough patients with significant breathlessness in P3, the trial will also fail, but it's unlikely considering the criteria for participation. Big question is, if regulators were happy to talk about approvals on the back of a 220+600 participant data, what are they going to say if P3 returns, say, optimistically, 500 "valid" data points +69 from P2. That's 70% of the target population. What's then? SNG trying to change the rules of the game after the game has already started?Approval or more trials? Your guess as good as mine.
Effectiveness is still not 100% guaranteed anyway, because it took the scientists months to come up with a way to manipulate the failed P2 data to actually get a positive story out of it (on the back of 69 participants picked out of 220), hence the long faces in the last presentation.