Biotech Values

[jq1234]

I know quite well. I might be biased because I had direct interest with one party at that time. I strongly believe FDA would have granted approval to both similar to EU if the trial designs were similar and benefits were similar. FDA advisory panel voted 15-0 Replagal trial had NOT provided substantial evidence that Replagal was effective - the vote on Fabrazyme was 14-1 in favor. To me, it wasn't orphan drug status of Fabrazyme that kept Replagal off US market. It's in their clinical data. Even this year, they had to withdraw Replagal BLA.

EMA granted Fabrazyme approval under ‘Exceptional Circumstances’ which ended only in 2008 - convert to full approval.