Another post from the Dendreon Yahoo MBread the opinionby:...

Another post from the Dendreon Yahoo MB
read the opinion
by: britneyspearswetpanties 05/03/06 01:51 am
Msg: 199120 of 199123

Don't believe the shorts. And don't take my word for it, either.

Read the opinion yourself.

It has fundamentally changed the FDA approval game.

http://pacer.cadc.uscourts.gov/docs/common/opinions/200605/04-5350a.pdf

Note particularly the new right recognised by the Court that is now the law of the land, and will remain as such unless it is overturned by the Supreme Court:

"We conclude, upon applying the Glucksberg analysis and heeding the protected liberty interests articulated by the Supreme Court, that where there are no alternative government-approved treatment options, a terminally ill, mentally competent adult patient’s informed access to potentially life-saving investigational new drugs determined by the FDA after Phase I trials to be sufficiently safe for expanded human trials warrants protection under the Due Process Clause."

Don't let the professional hedge fund bashers fool you. This is HUGE.

The Court recognised a Constitutional Right to take unapproved, life saving drugs. This now recognised right exists regardless of what the District Court does on remand. The Court has told the FDA that it cannot prevent patients from taking, and drug companies from selling, these drugs.

Biotechs developing these life saving drugs now have a much stronger hand with everyone from potential partners to Wall Street to the FDA because they can sell their drugs prior to FDA approval and generate revenue, not to mention data.

It will obviously take some time for them to figure out how to take advantage of this development, but they will.

Regardless of what the District Court does on remand, for the time being the FDA's ability to bar sales has been permanently crippled, until and unless the Supreme Court reverses, which may never happen.

THIS IS MAJOR, MAJOR news.

that is all.