Legal And Financial UncertaintiesA $40M loss contingency was recorded due to the ongoing SEC investigation.
Regulatory And Clinical RisksInvestment 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.
Stock VolatilityGiven the ongoing high volatility in the stock, analyst is maintaining a HOLD rating until the stock can be meaningfully valued.