27.01.2016 09:07:41
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Your Attention Please: Thumbs Up Or Thumbs Down For NEOS?
(RTTNews) - If the FDA sticks to its deadline, Neos Therapeutics Inc. (NEOS) will get to know the future of NT-0202, its product candidate for the treatment of attention deficit hyperactivity disorder, or ADHD, later today.
ADHD is one of the most common childhood disorders and can continue through adolescence and adulthood. Symptoms include difficulty staying focused and paying attention, difficulty controlling behavior and hyperactivity (over-activity), according to the National Institute of Mental Health.
NT-0202, also known as AMPH XR-ODT, is an Extended Release (XR) Orally Disintegrating Tablet (ODT) formulation of Amphetamine Polistirex.
This is NT-0202's second detour with the FDA.
The company's New Drug Application for NT-0202, filed under 505(b) (2) pathway, and was issued a complete response Letter by the FDA in September 2013.
Addressing the concerns raised by the FDA, the company resubmitted the NDA for NT-0202 last July as a Class 2 resubmission. Whether or not NT-0202 is approved will be known today (January 27, 2016).
Will NT-0202 cross the finish line this time? Stay tuned.
Neos went public on the Nasdaq on July 23, 2015, offering its shares at a price of $15.00 each. The stock, which touched a high of $28.99 on August 27, 2015, now trades around $9.
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