Clinical trials data are the real "thing" regardless of what your or any other sources might say about drugs' safety and effectiveness.

Finally, OS is the "gold" standard in oncology. PFS is just a marker for OS. Sometimes it is meaningful and sometimes is not [vectibix is a good case and point]. Correlationship between OS and PFS is not simple or linear.

The more I think the more I am convinced that overwhelming majority of physicians treating their patients with off-label drugs do so based on their hunches and guesses instead of providing their patients with the best available and proven treatment approaches.

Indeed, if an average physician can make highly complicated decisions about drugs efficacy and safety in applications where drugs have not been tested then there is no need to conduct long and very expensive clinical trials!

Forcing physician to use drugs exclusively on-label will:

a) provide their patients with best medications with proven safety and effecacy in the specific applications instead of using drugs with very questionable efficacy and safety. [avastin and vectibix are good examples of drugs misuses].

b) Strictly on-label medication use will put very strong fire under regulatory agencies to expedite drugs approval processes.

Will DNDN hit today $14? This is the question, and I don't have an answer.
------------------------------------------------

"Apr 12, 2007 (M2 PRESSWIRE) --

Shares of biotechnology company Dendreon Corp., up fourfold in recent weeks, slid in premarket electronic trading Wednesday after JMP Securities downgraded the stock, saying it was near its fair price.

On March 30, a FDA panel said there is evidence Dendreon's prostate cancer vaccine, Provenge, could be effective"

It is not strange. It is incompetent.

Bingo: " FDA is setting a dangerous precedent regarding the review process of NDAs with PROVENGE and Xcytrin, creating what looks like a double standard between CDER and CBER filings."

IMCL follows various strategic objectives by releasing Erbitux clinical data:

a) The Regulation FD disclosure requirements leave a lot of room for interpretation. Consequently, it leaves a lot of space for IMCL maneuvers;

b) Clinical data release is the most powerful marketing tool any biotech has promoting its products. This is the most important IMCL objective;

c) Presently, in light of Vectibix clinical problems, IMCL likes to create as much problems as possible for AMGN Vectibix clinical trials recruitments creating as many delays for it development as possible. [The just announced successful Erbitux+chemo trial results, in the same H&N indication AMGN is trying to enroll patients, make AMGN life very difficult.]

With DNDN, one never knows.

Just a few simple questions:
1. DNDN has no partner for the drug development, marketing and sale. Why?
2. Does DNDN intend to market the drug all by itself?

These are my final arguments:

It is a very well known fact that good many drugs have done very good in small PhII trials and then failed miserably in large PhIII trials.

Furthermore, IMHO, DNDN's trial in question has been designed and executed in a way leaving plenty of room for data manipulation and misinterpretation.

Dear Mr. Miller,

Very ofter, in science at least, even 100 out 100 experts can be very wrong.

Do you remember the history of stomach & duodenum ulcers? Almost for centuries, all experts thought that milk was the best way to help these ulcer patients. Thanks God, just two Australian scientists thought differently...

I can go further reminding you that some people still think the Earth is flat.

Explaining something to some people, it is important to do it "easy", in a way they can understand. However, even this approach is not always successful...

Unfortunately, DNDN data did not demonstrate actual survival.

I carefully reviewed DNDN data. The data is very weak. By approving DNDN's drug, FDA will undermine the drug approval process supposedly based on integrity and soundness of clinical data rather than on someone guesses or speculations.

Such FDA action will be doing great disservice to cancer patients offering them unsubstantiated hopes.

FDA approval process is terribly flawed

<<"The applicant has not provided sufficient data to evaluate the efficacy of panitumumab therapy," Division of Biologic Products Team Leader Kaushik Shastri wrote in a Sept. 26, 2006 memo, noting that Amgen did demonstrate improvement in PFS. Despite the modest effect size, FDA reviewers rationalized that for this patient population, there are no other treatment options, and the benefit-risk assessment is favorable under accelerated approval guidelines.>>
There is another treatment option. It is Erbitux being already approved by the same FDA group.



<<In his statistical review of overall survival, Lead Mathematical Statistician Mark Rothman disagreed with this analysis and the usefulness of using PFS as a predictor of overall survival . "Among the 232 patients on the BSC arm, 175 received panitumumab after investigator ascertainment of disease progression," he said. "For the patients in the study, overall survival was practically equal between the two arms. So not giving the patients on the BSC arm any anti-cancer therapy until they had an investigator ascertainment of disease progression or died, and then giving 175 of the survivors panitumumab led to the same overall survival as giving panitumumab upfront to the patients on the panitumumab arm. This does not say much for the meaningfulness of a PFS event in its relationship with overall survival."

It is obviously clear that, in their (FDA) desire to approve panitumumab, FDA leadership decided to disregard and ignore the statistical science embedded in the foundation of the approval process.

"Advisory Committee voted 13-4 to recommend DNDN's Provenge immunotherapy for prostate cancer with very limited data (only 82 treated patients with just 21% increase in survival)."

This is good. The last weekend I attended a casino and played a roulette. At one moment "RED" numbers came 11 times out of 12 spins. This did and could happened only because the sampling was very small. However, my experience does not in any way invalidate laws of mathematics.

jbog, please provide a link for merck's talk yesterday.

Tia

This is NOT a surprise. CR were observed before in small Erbitux pancreatic clinical trials. These patients remained cancer-free for well over an year. I don't know follow up results for these patients.

Remember that pancreatic results were mentioned by BMS as one of the main driver for BMS/IMCL commercial agreement.

It is BMS & IMCL job to bring the "potential CRC cure" message to both medical community and directly to cancer patients.

"Potential cancer cure" message is a very powerful message. Mass media advertisement is a good way for bringing it to patients and surgeons with enormous benefits to both.

It is also the time for BMS & IMCL to go directly against AMGN's vectibix and DNA's avastin.

Unfortunately, IMCL's still has no CEO to move the company into the major Pharma league.

<<Merck KGaA highlighted for the first time a new positioning for Erbitux:
Erbitux: Potential for Cure.
It emphasizes Erbitux' superior efficacy not only compared to Amgen's Vectabix but potentially also vs. Avastin, at least in some patient segments.>>

This is a huge step in Erbitux marketing differentiating it from both Vectibix and Avastin.

The next important question for IMCL: will BMS and IMCL accept and aggressively promote the new Merck KGaA marketing approach?

Could not be any better. The combo patent should be the next.

See ImClone at $45 by ASCO together with a good CEO running the show.