Ardeis

A Biotech Triple Play: Dendreon, BioCryst and Arena

Wall Street totally misread (I my opinion tried to rig the game) with regards to Dendreon. Their CEO is in my opinion a professional who for the most part carefully guages his words. DNDN has a reputation of late for under-promising and over-delivering. And to set the record straight, it was the FDA, Dr Scher with his many undisclosed conflicts of interest while sitting on the Provenge Advisory Panel and later authoring "leaked letters" along with nebulous reports of death threats, and Dr. Pazdur who orchestrated the defeat of Provenge in 2007 behind closed doors despite the overwhelming vote the Provenge was both safe and effective by the panel (even while the short interest in DNDN soared in the face of hugely positive news!!) who tried to do an endaround. Well those days are over as DNDN is firmly in the driver's seat with a phenomenal data set in IMPACT and growing public awareness of how captured our FDA really is! As added evidence, a recent Supreme Court request for Dr. Pazdur's records, emails, memos during that ill-fated 2007 debacle took over a year to get a response and when he finally replied on the deadline day, he reply was that he had deleted all of those documents.......you be the judge of who did an end-around!!

MD in FL

Dendreon 2007 Annual Report and How Provenge Will Propel Company

It should be mentioned that the FDA has never explained why it delayed the approval of Provenge in 2007. Since that time, two close competitors of Dendreon had to terminate trials due to unexpected deaths leaving Provenge as the single, safest available alternative for this terminal disease versus the horrendous Taxotene. Likewise it is crucial investors and patients realize Provenge has already shown a 20% increased survival over chemo at interim results of the IMPACT trial, released by the company back in October and the final results are due sometime between now and the end of April. This is a very exciting time for immunotherapy.

Dr. Scott
Safety Harbor, FL

Updated Calendars of FDA Decisions and Clinical Trials

Please include Discovery Labs which has a Class I review of Surfaxin due on or before April 21st I believe.


On Jan 22 08:12 AM Ohad Hammer wrote:

> Very nice summary, Thanks!

Dendreon: The FDA's Commissioner Doth Protest Too Much!

In China, much worse befell the head of their food and drug committee last year. The FDA hides behind it's veil of rules. Congress will eventually intervene, I predict von Eschenbach will not be renewed as Chairman and Provenge will eventually get approved; possibly in Fall 2008 or most definitely 2009. Scher and Hussain should be prosecuted but I doubt that will ever happen. Martha Stewart did fall less of a crimial infraction that these two in my opinion!