>> I'm curious whether AGIX has to include those data points they threw out when they determine if there is a statistically significant regression in patients once all the data points are in? <<
If they do not include these data points in the statistical analyses, the reported metrics are essentially meaningless, IMHO.
>> I noticed you mentioned intent to treat - does the company have an obligation to show these numbers instead of the scans they actually analyzed? <<
The company is not obligated to report the ITT numbers to investors. However, Nissen and Tardif presumably want to submit their work for publication in a peer-reviewed journal, and such a submission would probably be considered deficient if it omitted the ITT calculations. It may be quite a while before this study shows up in published form.
>> When CART-II is said and done, does AGIX begin a phase III attempting to repeat CART-II results or just use ARISE results? Can they get a positive labelling based on a combination of CART-II and ARISE results? <<
In general, a large, randomized phase-2 trial can serve as one of the two “well controlled” studies the FDA requires for product approval. However, I think it’s pretty unlikely that CART-2 will qualify in this regard and hence AGIX will most likely have to run a second phase-3 trial.
>> I don't think this is possible [for ARISE] to show plaque regression and have no benefit in reducing SAE's - or at least extremely unlikely. <<
That’s interesting because I think this is one of the most likely outcomes from ARISE. An important question for investors is whether AGI-1067 will still be approvable if this occurs.
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