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Message: National Kidney Foundation -Abstract: BOM

I thought that is exactly where we are headed...another Phase 3 trial. 

I assume that would require an FDA supervised trial, this time with more accurate and focused targets.  If I understand it correctly, the trial won't need 18 months, but can be halted in 9 months if the data bears out what the earlier data indicated.  With 9 months of data and 2,000 patients, you can populate the patient year requirements fairly easily.  Presto, you then get a great Phase 3 trial, this time with kidney and heart and dementia properly accounted for.

As CS99 notes, this requires a big spend from a partner.  An SGLT2 drug company should be happy to finance this.  Eli Lilly, Pfizer, Merck, Jannsen, Boehringer...one of them should be easily roped in.

I suspect the virus has delayed all such negotiations.  But the FDA will not wait...so the time pressure must be on potential partners to sign up.  

Just my 2 cents.

Iconoclast

 

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