SVNT: Do you think the FDA will stick their neck out and approve a drug that causes 3 APTC and 10 non-APTC cardiovascular events in the Phase 3 treatment arms while there is none in the corresponding placebo arms.
More telling is the open-label extension trial showing subjects on pegloticase resulted in 2 APTC and 7 non-APTC cardiovascular events whereas again there was none in the placebo arms.
The key is even if gout progresses over a long time in some patients causing mortality in the end while they are on their regular medicine, pegloticase is shown in these trials causing mortality all on its own in some patients in a short period of time.
It's obvious that the FDA will put the onus on SVNT to come up with perhaps a biomarker or a screening program to weed out those patients who cannot tolerate pegloticase. With limited funds to burn, can they? Will they?
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