Mopar...I believe you outlined exactly what the holdup is. the company immediately said they intend to conduct the studies, however, they only have protocol set for intra-nasal study. My guess is they still need a protocol set for the Oral route of abuse.
That would explain why the company needs further direction from the FDA. they can commence the 1 study now but the other one needs setup. That could give us a slight delay on our timelines.
"The submission also includes abuse-deterrent studies conducted to support abuse-deterrent label claims related to abuse of the drug by various pathways, including oral, intra-nasal and intravenous, having reference to the FDA's "Abuse-Deterrent Opioids — Evaluation and Labelling" guidance published in April 2015."
Yes! They need to clarify this ASAP in a press release or the lawsuits are going to keep rolling in and the SP is going under $1. Shouldn't be an issue for them to clarify it (unless they did intentionally mislead shareholders).
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