Jun. 5 at 3:10 AM
$RZLT Notes from Jefferies:
-Tumor HI - they need to demonstrate 50% of 16 patients achieved a 50% reduction in glucose infusion. They already have 6/8, so in the remaining 8 patients enrolled, they just need 2 patients to achieve this 50% reduction. They remain confident they can complete the study this year.
-Submitting cHI data to FDA this month, expect FDA to take 60 days or so to review and then they expect to receive a letter in the fall outlining the next steps for the program. No discussion around doing another study at this stage. RZLT will not do another RCT even if FDA asks.
-They'll be prepared to file a BLA for tumor alone, cHI alone, or both in 1H 2027.
-And lastly my favorite quote: "There is no other explanation, when this is glucose, whether a drug is active and working when the child is only taking our drug."
