Just a note of clarification I added into caps the below extract:
The Parasol group recommended a reduction in proteinuria (spillage of protein into the urine) over 24 months as a surrogate endpoint for FULL REGULATORY APPROVAL of FSGS drugs.
But what about CONDITIONAL APPROVAL:
Conditions for Approval:The FDA may grant conditional approval if there's evidence supporting the drug's efficacy and predicting clinical value, or if the benefits outweigh the risks. Sponsor's Responsibilities:The drug sponsor (company) has the responsibility to generate the additional data required to meet the FDA's "substantial evidence" standard for full approval within a specified timeframe, typically five years.
And side note this ZyVersa company is years behind dxb.
so yes, the fda feedback looks like it will be very interesting.
DXB Price at posting:
34.5¢ Sentiment: Buy Disclosure: Held
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