Provention Bio rollercoaster continues with generally positive remarks from FDA ahead of Thursday’s adcomm
Early last month, Provention Bio’s shares cratered after disclosing that the FDA found the pharmacokinetic profiles of its potential type 1 diabetes drug, acquired from Eli Lilly, differed when manufactured by Lilly versus Provention.
At the time, the FDA said its concerns meant that it was not ready to start post-marketing and label discussions with the company.
But now, two days ahead of the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee meeting to discuss the drug, known as teplizumab, the FDA sounded a relatively positive tone on safety and efficacy. The company’s stock was up about 30% early Tuesday.
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