The Equity Committee in the Biovest Chapter 11 case recently filed the attached "Motion to Appoint an Examiner or Chapter 11 Trustee." According to the Motion, "recent information has been uncovered demonstrating that the Debtor has, since 2005, consistently misrepresented to the public the status of its efforts to obtain FDA approval for its principal drug" (page 1).
The Equity Committee argues that "the Court shall order the appointment of a trustee
'for cause, including fraud, dishonesty, incompetence, or gross mismanagement of the affairs of
the debtor by current management' ."
According to the EC: "In just the very brief discovery
taken in connection with the DIP financing, the Committee discovered evidence that the Debtor
mishandled the process for FDA approval and misrepresented the status of the process to the
public. Despite the Debtor expressing publicly its surprise in 2012 at not receiving FDA
approval of its Phase 3 study for BiovaxID, FDA meeting minutes detail how FDA, beginning in
2005, informed the Debtor repeatedly that the "design, conduct, and statistical analysis" of its
Phase 3 study were deficient. FDA informed Biovest in 2008 and 2010 that its Phase 3 study
was "on its face scientifically incomplete to establish clinical evidence of effectiveness."
Biovest failed to inform the public about its meetings with, and communications from, FDA in
2005, 2008, and 2010.
"Nor did Biovest inform the public about FDA's findings during those years of (a) the inadequacy of the Phase 3 data for demonstrating safety and efficacy of BiovaxID, and (b)
the impropriety of Biovest's statistical analysis of that data. On the contrary, Biovest led the
public to believe (a) that Biovest had not presented its Phase 3 data to FDA until 2012, and (b)
that the data, and Biovest's statistical analysis of the data, could be acceptable to FDA. In fact,
however, FDA had repeatedly told Biovest
luv, I was swooping down to find the same-ole-same-ole -- last thing expected was the contents of your post. first of all, thank you -- I cannot pretend not to be stunned...I've been fighting off a gnawing disdain towards these medical doctors running the company, but hey, I know people who can ply both trades....but this is beyond incompetency!! this is about irresponsible ego run rampant, superceding the good of everything -- the company, the shareholders, the FDA, and last but not least, the very patients this drug was supposed to help! The damage done is deep here...I always look to litigation as the last resort -- kind of like surgery -- let's start out with the least unobtrusive alternatives....but THIS is exactly what litigation is meant to target -- criminal behavior. I am outraged and hope people here familiar with legal process speak out!