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Why a Big Delay From the FDA Has Amicus Therapeutics Shares Crashing

Amicus Therapeutics Galafold application has already been filed for approval in Europe and a decision from EU regulators is expected in the first half of 2016.

Now what:

It's unclear whether or not the FDA's desire for more information suggests the EU will similarly press the pause button, but if EU regulators are satisfied, then Galafold could become available in European markets by the end of next year.

Assuming Amicus gets its ducks in a row and completes a filing in the U.S. in 2016, then it could receive a go-no-go decision on Galafold at some point in 2017. Obviously, winning approval for Galafold in both markets is ideal; however, if Galafold doesn't get approval in the U.S., but does get approval in the EU, then it could still become a top seller for the company.

In 2012, pushback from the FDA led to Shire yanking its application for the Fabry disease drug Replagel and although Replagel is only approved in Europe, its sales are still running at an annualized pace of $468 million exiting the second quarter.

Regardless, this FDA delay is a blow to investors hoping for a quicker path to profitability; especially following the company's recent spending to acquire Scioderm in order to get its hands on the late stage drug Zorblisa, a therapy for a rare pediatric condition.

Overall, a delay in an FDA filing is concerning, but the potential for an EU approval next year, an opportunity to file for approval of Zorblisa by 2017, and a solid balance sheet makes Amicus Therapeutics a company that risk-tolerant investors may want to consider buying on sale.

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The article Why a Big Delay From the FDA Has Amicus Therapeutics Shares Crashing originally appeared on Fool.com.

Todd Campbell owns shares of Amicus Therapeutics,. Todd owns E.B. Capital Markets, LLC. E.B. Capital's clients may have positions in the companies mentioned. The Motley Fool has no position in any of the stocks mentioned. Try any of our Foolish newsletter services free for 30 days . We Fools may not all hold the same opinions, but we all believe that considering a diverse range of insights makes us better investors. The Motley Fool has a disclosure policy .

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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.


The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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