BE BRAVE.....

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Anonymous

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We abandon the Replagel for Fabry disease because it isn't financially lucrative - FDA wants more clinical trials. "To be as brave as the people we serve". Way to go leadership!
 












They're not holding anything back. FDA always does this... oh you're approved in EU just submit to us so we can make it official and you can sell in the US.

Oh - thanks for the filing and the PDUFA payment of >1MM ... now hummm we think you need 1 or 2 more Phase 3 studies.

FDA laughing all the way to the bank. Shire got taken.
 












Shire isnt brave. They are just every other Pharma. PROFIT PROFIT AND PROFIT. Everyone is so scared to challenge the status quo. In fact, all the money being thrown around and wasted no wonder so much of their workforce is contract work. The company can't afford to bring on perm ee's. Maybe current ee's should stop flying business class and staying at five star hotels. Maybe being BRAVE means you treat your contractors better because they are the reason the perms have all their benefits.
 






So true. To be BRAVE is to lose your job. Reliance on contractors may save money but doesn't get products through the pipeline. Rumor has that the FDA found serious issues with many aspects of the Replagal filing. Things that the company tried to throw under the rug. Rumor has it that the same thing will happen with Replagal in Canada and the European Union once they become aware of the issues. Be BRAVE, stay put.
 












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