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DewDiligence

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DewDiligence

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Re: xrymd post# 12460

Friday, 09/12/2014 5:03:34 PM

Friday, September 12, 2014 5:03:34 PM

Post# of 20689
Synthon acknowledged receiving a CRL from the FDA for their Copaxone ANDA in 2013. It’s unclear whether they’ve responded to the CRL.

The clinical trial they conducted should put Synthon in good shape to get approval in the EU, where (unlike the US) Copaxone is regulated as a biologic.

“The efficient-market hypothesis may be
the foremost piece of B.S. ever promulgated
in any area of human knowledge!”

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