Mar. 4 at 4:54 AM
$AARD (AARD Management Incompetence part 2) In this other, unreported phase 1 study to try to "cover" the higher dose in the HERO trial, AARD incompetently didn't even look for cardiotox, the known marker. Or, even worse, it was covered up, hence the audit. Intelligent PK could have figured this out and avoided this surprise of exceeding the systemic lidocaine levels.
What needs to be done is to figure out proper PK for systemic levels and investigate rage of systemic absorption at higher doses. Once this is understood, the known cardio side effects can be managed with clear label dose information.
In summary, this isn't a problem with the drug. It is a problem with incompetent management who failed to execute this drug preclinical and clinical development. It may take a shareholder fraud lawsuit to get the Board to step up and fix this. The Board has a fiduciary duty to the shareholders and the Board failed to fulfill their fiduciary obligations. Time to relieve them of their money.
