Thank you senti. Im sorry for my frustrated language towards the shorts.
The FDA had indicated a wish list for ECAs in the Anals article they wrote a few years ago… however, IMO (and I am the last person to be an expert in this, so my opinion isn’t worth too terribly much), obtaining patient level from other biotech and pharmaceutical trials is pretty much impossible, unless you owned the trial data. So good luck with that.
Exactly. According to the shorts, no biotech can ever conduct a medical trial based on ECA comparison because no biotech will be able to get individual patient data. The reality is that this deep level of individual patient ECA data is NOT what the FDA requires for a biotech to possess to be able to conduct an ECA comparison medical trial.