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Buy Amicus Therapeutics, Inc. (NASDAQ:FOLD) On The Dip

Buy Amicus Therapeutics, Inc. (NASDAQ:FOLD) On The Dip
Written by
Chris Sandburg
Published on
July 13, 2017
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Back in November 2016, Amicus Therapeutics, Inc. (NASDAQ:FOLD) looked dead in the water. Well, perhaps as little harsh. Not that in the water, but privy to a severe setback and one that markets initially interpreted as likely to drag out the companies lead development program across a period of 2 to 3 years subsequent to be the setback in question. Preset back, the company went for $9.20 a share at its peak. Subsequent to the development, this dipped to mid-December lows of $4.84.Fast forward six months, and everything has changed.Before getting to how and why, let's quickly outline what happened initially. The company has a drug in his portfolio called Galafold, which is trying to get approved as a treatment for patients with Fabry disease in the US. It is already approved in Europe and – prior to the final quarter of last year – look like a strong candidate for approval in the US. However, in November, the FDA said it was unwilling to give the drug a regulatory green light in this indication without additional data supportive of both the efficacy and safety side of the treatment.That's what caused the company to collapse. During the subsequent few months, however, Amicus got to work with what is perhaps best described as a lobbying effort to change the regulatory agency's mind. Its justification for doing so is relatively straightforward. In patients with this disease, and elevated level of a fatty substance called GL-3 builds up in vital organs, including the kidneys. This elevated GL-3 level causes a number of complications, including some of those most seriously associated with the disease – pain, kidney failure, heart disease, and strokes.With the underpins its application for approval in the US, Amicus was able to demonstrate that treatment with Galafold reduces the GL-3 level in patients and – by proxy – helps to avoid buildup in the major organs noted above. The company had submitted on the assumption that the reduction of GL-3 buildup would be enough to warrant approval based on the fact that weather, legacy data demonstrates the connection between reduced GL-3 and reduce the risk of heart disease and strokes.Initially, the FDA didn't agree. The agency came back to the company suggesting that he needed to produce data of its own that demonstrated this link – data that could've taken anywhere between 24 to 48 months to collect ahead of a resubmission.On the back of the company's lobbying, however, the FDA has now changed his mind. This week, the agency reported that it would be willing to accept the Amicus Galafold submission in its current format and – subsequent to its acceptance – consider the drug for approval in this indication.So what is next?Well, the chances of approval on this one incredibly high. Normally, the acceptance of an application by the FDA doesn't really offer any insight into its underlying opinion of the approved ability of the group in question. In this instance, however, with the agency having already spent a considerable amount of time looking at the data and – subsequent to this – changing his mind as to whether it is willing to accept the application in its current form, we think there is a strong chance of this one one picking up approval come PDUFA.The company seems to agree, having almost immediately subsequent to the FDA decision announced a raise of $225 million, the vast majority of which we expect will go towards executing on a commercialization strategy for the drug in the US.So how might an investor latest one now? Well, the company was actually trading higher than its pre-November highs ahead of the FDA decision, but the latest raise announcement has served up what we see as nice opportunity to buy in on the dip.We will be updating our subscribers as soon as we know more. For the latest updates on FOLD, sign up below!Image courtesy of Owen Moore via FlickrDisclosure: We have no position in FOLD and have not been compensated for this article.

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