At the time that NVX was being asked to provide additional information
to the FDA , Jan 12th or so time frame, all the other vaccine manufacturers
were receiving "warning letters" from the FDA requesting information, so
I undersrtand.
It is my understanding now that the "WARNING LETTERS" went further than
that. Alot of drug companies got letters, apparently .
One "astute investor" relates all this to the "fen phen/redux"
situation. I am talking about the diet pill class action suit involving
AHP, SKB, and at least four othwer smaller drug companies. The suit
centers on "adverse event reporting" .
In the vaccine industry we have VARS. I do think we will be seeing more
post marketing studies become the norm and just perhaps an FDA
requirement on all drugs.
NVX for the past two years has been doing just that with CERTIVA in
Sweden. They have conducted the only large scale Phase IV clinical study
on a DTaP vaccine ever. The results have been fantastic as we are all
aware. It won't take but a very little bit of public education to make
this a very essential step to having an acceptable drug/vaccine on the
market.
The "astute investor" does indeed think that the "Fen Phen/Redux"
suit is having its effect on FDA policies and procedures and in time
will get alot more attention from the public. " The FDA is taking the
neccesary steps to force compliance with monitoring and reporting
adverse events of all approved drugs."
Today , we all know that the DTaP vaccines that are now on the market do
experience adverse events , some of which are serious. We also know they
vary by manufacturer and by"lot".
There is an 800 number that will tie adverse event occurrence to lot
number by manufacturer. Surprisingly they can't manufacture to a
standard so there is variation among lots. That to me is scary. The
"astute investor" thinks the FDA may be clamping down on this problem
and that may account for so many "warning letters".
Now I will tell you NVX's CERTIVA doesn't vary from lot to lot. It is
highly pure, the D, T, and aP . If you are multicomponent, you got a
bigger problem ,. A lot bigger.
Now that is just part of why i think NVX will some day have all of the
DTaP business. :-} |
