Seelos Therapeutics Inc (SEEL)

[Bryce Harper]

They even admit under Risk Factors in their latest filing that they have little experience with the FDA regulatory process. That sure showed last October when they were spouting that they had been communicating with the FDA all along and were anticipating resubmitting the NDA within days after their November meeting with the FDA. Then they found out at the November meeting that their methodology was trash and that they needed to rewrite the whole thing under a different methodology. On top of that, they had no idea until the November meeting that they had to do a Human Factors study on the use of the device even though the FDA published its Human Factors study guidelines in February 2016.