Osmotica plunges on FDA complete response letter

 

• The FDA has issued a complete response letter (CRL) regarding Osmotica Pharmaceuticals (NASDAQ:OSMT) new drug application for arbaclofen extended release tablets to treat spasticity resulting from multiple sclerosis.
• The CRL stated that the Company did not provide adequate justification (including in its most recent NDA amendment) for the statistical analysis of the change from baseline to Day 84 in TNmAS-MAL scores comparing arbaclofen 40 mg to placebo, one of the co-primary endpoints.
• The FDA made a number of recommendations in its CRL, including that the Company conduct a new study in order to provide substantial evidence of efficacy of arbaclofen.
• The Company intends to review the CRL with its advisors and to request a meeting with the FDA to discuss their recommendations.
• Osmotica Pharma rose 19% on Dec. 28 ahead of expected arbaclofen PDUFA.
• OSMT -27.6% after hours to $3.83
• Press Release
• https://seekingalpha.com/news/3647810-osmotica-pharmaceuticals-plunges-27-on-fda-response-letter