Biotech Values

[DewDiligence]

Re: Preliminary Clevudine phase-3 results

I’ve reformatted the tables in the
PR for better comprehension:

% e-positive patients 
 w HBV DNA<300 copies/ml 
   
 Wk-24  Wk-48  Wk-60 
  53%    68%    31% 
   
 % e-negative patients 
 w HBV DNA<300 copies/ml 
   
 Wk-24  Wk-48  Wk-60 
 100%   100%    92%

Back to the Pharmasset PR:

>To our knowledge, Clevudine is the only HBV therapeutic agent, investigational or approved, that has demonstrated potentially clinically meaningful SVR levels at 12 weeks and 24 weeks post-treatment.<

Note how they use the waffle word “potentially” in this context. I would certainly object to calling these results SVR’s because I do not see where Pharmasset has established that relapses are no longer occurring, particularly in the e-negative group where relapses have been extremely common with other antiviral agents.

Also, one has to wonder if the patients selected for this preliminary analysis have been cherry picked from what is a large phase-3 trial.

Clevudine is a drug to watch, but this PR strikes me as hyped. JMHO, FWIW