Clinical TrialsInvestment thesis risks include failure of clinical trials to prove efficacy, regulatory requirements for additional clinical studies, and potential need to raise additional funds under poor market conditions.
Regulatory InvestigationA $40M loss contingency was recorded due to the ongoing SEC investigation, and there is no agreement with the SEC but management has enough information to estimate a financial loss.
Stock VolatilityGiven the ongoing high volatility in the stock, analyst is maintaining a HOLD rating until the stock can be meaningfully valued.