There are several reasons that investors are excited here. First and foremost, the FDA agreeing to allow the company to take the Accelerated Approval pathway to bring this drug to market is great in and of itself. The pathway will ultimately shortent the distance from application to decision from the regulatory agency.
Moreover, Fabry disease is a very serious condition. Unfortunately, while there are some approved treatments on the market for the condition, there aren’t many options. Moreover, currently approved options may not work for large portions of this patient population.
Previously released data suggests that PLX may be onto something here. If the Phase III study closes with data continuing to be very strong, the company may have the potential to take a large share of the market. According to Grand View Research, that market will grow to be worth more than $3 billion annually by 2025.
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