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network_engineer

07/07/20 1:35 PM

#1244 RE: Beatcovid #1240

Treatment of cystinuria has nothing to do with COVID-19.

Different treatment. Cannot compare.

Cystinuria is caused by too much cystine in the urine. Normally, most cystine dissolves and returns to the bloodstream after entering the kidneys. People with cystinuria have a genetic defect that interferes with this process. As a result, cystine builds up in the urine and forms crystals or stones.
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MrNormall

07/07/20 1:39 PM

#1245 RE: Beatcovid #1240

It was an application for an Orphan Drug Indication in 2015. At that time it didn't make sense to have it under that classification.

The Phase 3 bucillamine for Covid is a whole new ballgame.

Apples and oranges...
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powerbattles

07/07/20 1:53 PM

#1247 RE: Beatcovid #1240

WRONG! "Not FDA Approved for Orphan Indication" That doesn't indicated The FDA shot down Bucillamine.

Orphan Drug Status Orphan status does not mean that FDA has approved the drug. Orphan status and FDA approval are not the same. The approval of an orphan designation request does not alter the standard regulatory requirements and process for obtaining marketing approval.

https://www.accessdata.fda.gov/scripts/opdlisting/oopd/listResult.cfm