A 'disoriented' Pain Therapeutics flips out after FDA rejects appeal on Remoxy
Pain Therapeutics has had the last word on its four-time reject Remoxy — and it’s a bitter one.
After a meeting with the FDA, the biotech says, “we believe we are no closer today to product approval than we were over a year ago” thanks to “shambolic regulations” at the agency.
Its stock $PTIE promptly fell 20%, tumbling further into pennystock lowland.
The dispute here centers around how easily Remoxy — an extended release gel formulation of oxycodone — can be abused, at a time the deadly opioid crisis has led to calls for heightened vigilance over approval of new pain drugs.
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