phil_vardena

Hansen Medical: A Stock to Make Any Investor's Heart Happy

And what about the 8% drop the day follwing that?


On Nov 12 07:15 PM Jason Kelly wrote:

> Uh, gang: read a little more carefully next time, and note the abundance
> of sarcasm. Note, too, the position disclosure.
>
> The article was partially tongue-in-cheek to show that even cooked
> books can't keep a stock down in this environment. The one-day 18%
> pop following the posting proved the point.

Hansen Medical: A Stock to Make Any Investor's Heart Happy

Author, you did not do your dd.

HNSN has a bad safety profile. We know of at least one death, but we also know that HNSN under reports its safety accidents. They have a 4-8 % safety issues overall, depending on the ability of the clinician - in line with manual ablations. So, if results are in line, why switch to robotics?

STXS has an excellent safety profile. They have done many more cases and their accident rate is 0.1%, with no deaths. Learning curve is favourable and even if the clinician makes a mistake, the floppy catheter is not able to perforate the cardiovascular system.

Scientific literature is 20 to 1 STXS vs. HNSN. Leader clinicians around the world are endorsing STXS and dumping HNSN.

Just take a look at how many senior managers left their jobs at HNSN during the last year or so and ask yourself why?

Your puff piece about HNSN is so inaccurate it is beyond any comment.

A last one. Just because their share price collapsed from 30 to 3, it does not mean they will see 30 ever again.

No, the last one is that HNSN does NOT have approval to treat any kind of arrythmias, they have FDA approval for mapping only. When the clinician uses Sensei for ablations they do so off-label; while STXS has everything FDA approved for ablations...

I expect the FDA to step in and close HNSN down for good anytime.

I am long STXS...

How Much Is Dendreon Worth?

I said "For simplicity's sake (but it should not be much far from reality) I assume there will be 100,000,000 DNDN shares (2007 annual report share count is 82,531,000)."

Are you able to read?


On Apr 20 04:13 AM provengers666 wrote:

> Hey, Phil....you just lost all credibility...for someone who purports
> to have such strong opinions, you might want to at LEAST tell people
> what the most current share count is....hint: it's a LOT higher than
> the 82 million you referenced, and it will likely become much higher
> within the next year as the company raises money to develop the other
> drugs in the pipeline.....also, you might want to mention that any
> European sales will be much less profitable as they have to share
> the proceeds with the partner....that said, it seems to be a good
> candidate for a run to $30 in the near term...anyone who tells you
> they can predict the longer term is full it...

Is Dendreon a $360 Stock - Or Is That Too Low?

The FDA chose not to approve Provenge, even though it was advised (on March 29, 2007) by its appointed panel of Oncologists, Urologists, and Immunologists, all experts in the fields of immunotherapy and oncology, that Provenge is unquestionably safe (100% of the experts voted yes on safety) and that there was “substantial evidence” of the drug’s effectiveness as required by FDA regulations (76% of the experts voted yes on substantial evidence of effectiveness).
Among the NOs, Dr. Sher and Dr. Hussain.

Provenge achieved a 200% increase in overall survival measured at 3 years… with multiple recipients alive and well over 6 years later.

27,000 men with end-stage prostate cancer will die needlessly early (some will die needlessly period) each year the Provenge is delayed by the FDA.

Certainly FDA has approved drugs against the recommendations of its advisory panel, but I am not aware of a decision to overrule a strong positive panel vote for a terminal illness that has no really acceptable treatment options. This decision would appear to be unprecedented, and calls for a full and open public statement of why the FDA disagrees with this panel and cannot make this drug available to terminal patients. We know of course it was not due to safety concerns. Also, if FDA found the clinical trial data submitted by Dendreon (Provenge producer company) to be insufficient, why did it even submit the data to a panel of experts for their opinions?

Some of those doctors that voted “NO” as to the effectiveness evidence even had letters (urging the FDA NOT to approve Provenge) “leaked” to the media. They were Dr. Sher and Dr. Hussain. I let you judge on the ethics of this behaviour.

On May 30, 2007, news was that Schering-Plough Corp. said it had agreed pay Novacea Inc. up to $440 million for rights to develop the smaller drugmaker’s prostate cancer treatment, causing Novacea shares to double.
Both Dr. Sher and Dr. Hussain are Novacea consultants.
Do you think Schering-Plough would have paid $60 million immediately and an additional $380 million to Novacea if Provenge was on the market?

Why the FDA - for the first time in its history - did not approve a drug deemed safe and effective by its own panel?
How is that Dr. Sher and Dr. Hussain - with their obvious and enormous conflicts of interest - took part in the panel?
Who did choose Dr. Sher and Dr. Hussain?

We already have proof that Provenge works (two phase III trials). Many people are going to die due to the delay. Who is accountable?
Why isn’t this revolutionary and extremely safe treatment available NOW?
I can’t imagine the motives are about monetary gains.

There's now a third pIII trial that shows that Provenge works (details tuesday 28 april 2009).

Since the FDA issued the Approvable Letter and delayed patient access to Provenge, 59,511 men have now suffered painful deaths from prostate cancer. Provenge could have likely extended the lives of many of them for months, and for some, perhaps years. It could have spared some of them the horrible side effects of chemo treatments.

Many more men continue to be unnecessarily at risk for a premature and painful death due to the lack of approval and availability of this life-saving cancer therapy, despite the fact that we received crystal clear confirmation that Provenge works and works so well that it met its trial endpoints "unambiguously" and "robustly". Until Provenge is approved by the FDA, the advance of immunotherapy technology generally, which is inherently better and more promising than chemotherapy and other current treatments, as well as many other progressive medical technologies desperately needed by sick and dying patients, continues to be stymied.

WHO IS ACCOUNTABLE?

Is Dendreon a $360 Stock - Or Is That Too Low?

There are around 220,000 men diagnosed with prostate cancer, every year, in the USA.

I think that, within a few years' time, every single one of them will ask and have treatment with Provenge.

But let's assume 80,000 will take it.

Each Provenge treatment will reportedly cost $40,000 (I mean the whole treatment: blood taking, then three infusions),

80,000 x 40,000 = € 3,200,000,000.00.

In a few years' time, with stabilization of financial market, DNDN might fetch 10x sales.

This gives me a market cap of 32,000,000,000.00.

For simplicity's sake (but it should not be much far from reality) I assume there will be 100,000,000 DNDN shares (2007 annual report share count is 82,531,000).

This gives me a pps of $320.00.

This excludes ROW (almost a triple if we just count the EU, Japan, the so-called "western world". Think India, think China....... vbg)

All of the above excludes:
1 - Neuvenge;
2 - the treatment that DNDN will be able to develop against Carcinoembryonic antigen (CEA) - actually in pre-clinical phase - lung, colon, breast cancer;
3 - Carbonic anhydrase IX (CA9) - cervical, colon, renal, cancers (pre-clinical phase);
4 - the small molecule against Trp-p8 - prostate, breast, colon, lung cancers (moving from pre-clinical into clinical phase).

This is a revolution: many people, diagnosed with cancer, will live longer and better thanks to Dendreon.

How Much Is Dendreon Worth?

There are around 220,000 men diagnosed with prostate cancer, every year, in the USA.

I think that, within a few years' time, every single one of them will ask and have treatment with Provenge. But let's just assume they will be 50,000.

Each Provenge treatment will reportedly cost $40,000 (I mean the whole treatment: blood taking, then three infusions),

50,000 x 40,000 = € 2,000,000,000.00.

In a few years' time, with stabilization of financial market, DNDN might fetch 10x sales.

This gives me a market cap of 20,000,000,000.00.

For simplicity's sake (but it should not be much far from reality) I assume there will be 100,000,000 DNDN shares (2007 annual report share count is 82,531,000).

This gives me a pps of $200.00.

This excludes ROW (almost a triple if we just count the EU, Japan, the so-called "western world". Think India, think China....... vbg)

All of the above excludes:
1 - Neuvenge;
2 - the treatment that DNDN will be able to develop against Carcinoembryonic antigen (CEA) - actually in pre-clinical phase - lung, colon, breast cancer;
3 - Carbonic anhydrase IX (CA9) - cervical, colon, renal, cancers (pre-clinical phase);
4 - the small molecule against Trp-p8 - prostate, breast, colon, lung cancers (moving from pre-clinical into clinical phase).

I have a substantial (at least, for me!) position into DNDN and plan to buy more with full hands as soon as the FDA will approve Provenge. And the hell with diversification! I'll sell my first batch at $80, my second at $400 and will sell the rest later and will retire early!

This is a revolution: many people, diagnosed with cancer, will live longer and better thanks to Dendreon.

phil

Dendreon's Provenge: Government Agencies Play Hide and Seek With Facts

One last comment.

Probably the most important point is that we know Provenge is aimed at end-stage, dying prostate cancer patients. These people do not have choices.
If you want, please repeat with me: these people do not have choices - and are going to die anyway.

Provenge has been voted safe! 17-0! Even the conflicted doctors voted it is safe!
What's the downside of giving Provenge to the dying?

The British now have hospitals where experimentation can be used on patients who request it. As I understand it, it can go beyond what's being tried in the clinic, it can go to treatment that Doctors and Patients agree to. The advantage of such a program is that anecdotal data can be gotten on different uses of drugs which if effective can result in additional trials to see if the results can be duplicated.

The FDA is not permitting such experimental work, even for those willing to try it and also willing to sign off all legal claims against those treating them. I'm not suggesting that drugs untried in people be used experimentally first, but after they're proven safe in a Phase I and have advanced to Phase II they should be made available as long as documentation's provided on how they're to be used, and why they've been selected for the specific application.

I strongly believe that the USA fail to equal or exceed acts like what the British are doing it won't be long before they're no longer a world leader in drug development. The FDA's been driving up the cost of US approval, while extending time to approval tremendously; this might be fine to determine a headache medicine is completely safe, but it's not fine for a drug designed to benefit the victims of terminal diseases like cancer. It's time to take Approvable out of the FDA vocabulary, especially if people are dying waiting for the drug. An approval with any number of conditions that must be met is fine, as long as it still means that people who need it can get it after the approval.

Dendreon's Provenge: Government Agencies Play Hide and Seek With Facts

Do you remember Imclone?

Sam Waksal's daughter had sold 2.5 million dollars worth of ImClone shares on December 27, 2001, the day before the announcement and subsequent stock decline.

The next day, there were rumors that Martha Stewart may also have sold in advance of the news, thanks to a direct tip from her friend, Sam Waksal.

On June 9, the Wall Street Journal says that Harlan Waksal knew three days in advance that the FDA would reject the Erbitux application.

Later, it would become clear that Alan Bennett, a lawyer for Bristol-Myers in Washington, had sent an email to Harlan Waksal and Bristol-Myers management saying that Richard Pazdur, an FDA employee, told him the Erbitux application would be rejected the following Friday, which turned out to be the case.

On June 12, Sam Waksal was arrested by the FBI on insider trading charges.

Martha Stewart was arrested and served prison time.

Dr. Richard Pazdur is still at the FDA…

Dendreon's Provenge: Government Agencies Play Hide and Seek With Facts

The FDA chose not to approve Provenge, even though it was advised (on March 29, 2007) by its appointed panel of Oncologists, Urologists, and Immunologists, all experts in the fields of immunotherapy and oncology, that Provenge is unquestionably safe (100% of the experts voted yes on safety) and that there was “substantial evidence” of the drug’s effectiveness as required by FDA regulations (76% of the experts voted yes on substantial evidence of effectiveness).
Among the NOs, Dr. Sher and Dr. Hussain.

Provenge achieved a 200% increase in overall survival measured at 3 years… with multiple recipients alive and well over 6 years later.

27,000 men with end-stage prostate cancer will die needlessly early (some will die needlessly period) each year the Provenge is delayed by the FDA.

Certainly FDA has approved drugs against the recommendations of its advisory panel, but I am not aware of a decision to overrule a strong positive panel vote for a terminal illness that has no really acceptable treatment options. This decision would appear to be unprecedented, and calls for a full and open public statement of why the FDA disagrees with this panel and cannot make this drug available to terminal patients. We know of course it was not due to safety concerns. Also, if FDA found the clinical trial data submitted by Dendreon (Provenge producer company) to be insufficient, why did it even submit the data to a panel of experts for their opinions?

Some of those doctors that voted “NO” as to the effectiveness evidence even had letters (urging the FDA NOT to approve Provenge) “leaked” to the media. They were Dr. Sher and Dr. Hussain. I let you judge on the ethics of this behaviour.

On May 30, 2007, news was that Schering-Plough Corp. said it had agreed pay Novacea Inc. up to $440 million for rights to develop the smaller drugmaker’s prostate cancer treatment, causing Novacea shares to double.
Both Dr. Sher and Dr. Hussain are Novacea consultants.
Do you think Schering-Plough would have paid $60 million immediately and an additional $380 million to Novacea if Provenge was on the market?

Why the FDA - for the first time in its history - did not approve a drug deemed safe and effective by its own panel?
How is that Dr. Sher and Dr. Hussain - with their obvious and enormous conflicts of interest - took part in the panel?
Who did choose Dr. Sher and Dr. Hussain?

We already have proof that Provenge works (two phase III trials). Many people are going to die due to the delay. Who is accountable?
Why isn’t this revolutionary and extremely safe treatment available NOW?
I can’t imagine the motives are about monetary gains.

6 Medical Device Makers Poised for Growth

You say that "HNSN has received FDA approval". That's true for mapping, but not true for anything else. The use of Sensei as a tool for cardiac ablation is "off label" and open to lawsuits.

Also your statement "Among the medical community, it is believed that the Sensei system is better, as well as being cheaper" is ambiguous. "Medical community". Look, the HRS 2008 starts in a few days. 90% of core abstracts revolve around the use of Remote Magnetical Navigation devices, which means Niobe, which means Stereotaxis. Is the Sensei better? Simple math doesn't say so.

Adverse effects with Stereotasis' Niobe represents less than 0.1% of 15,000 procedures.
Sensei gets something north of 6%. Is the Sensei better? I wouldn't undergo a procedure with Sensei even if well paid!

Regards,
phil