Andrew Horowitz

Dendreon: I Want the Truth

Kar:

I think that your information is well researched and it is rather thought provoking. I am a long holder as well as my clients and I have written a few articles on this subject (DNDN) as well. I look at your blog and I see nothing about who you are and if you are long for just you, clients or ????

I think that if you expand your bio it will bring much more credibility and maybe it will open a few more eyes. Still, while I think about the oddities with this mess, I wonder why these seemingly respected Doctors and other panel members voted the way they did... Truth be said, it was a few LOUD remarks that gave the panel the PAUSE signal and 50% of them have a clear conflict. Actually, so much so that one has to ask how they can have such incredible cahonayes to manipulate the system with so many watching (not to mention the lives at stake). Another truth is that you will never get the truth on this one. There is way too much confusion created by the ones with the $$$$$$. So, as you, I am sorely dissapointed with the outcome of the FDA meeting and feel that there is something not quite right. I am not so sure that there is anything we can do but wait until the DNDN delivers their next result to the FDA and the results should speak for themselves.

You have to admit that the biggest concern is that the safety data was very encouraging and even if Provenge was only mildly effective, there should have been leniency as there are limited viable alternatives to PC patients at this time. Why not at least approve with an oversight requirement while the company continued testing. This would have allowed for all to be happy. Again, it was not seen as harmful which should be the first concern of any drug on the market. (As even the placebo effect can help the body mend itself in some situations)


As per the short selling issue: I have seen first hand the process of shorts unable to be delivered. Trading firms offer their clients shorts up to , say 10,000 shares on a stock for almost all stocks that trade. Then, when it actually comes to the part about delivery, it never happens. The requirements to short are very clear and at the very essence, is the ability for brokerages to lend "eligible" stocks to the short sellers from other accounts, which also has clear rules that were created by the SEC.


V. Rule 203 — Locate and Delivery Requirements for Short Sales
A. "Locate" Requirement

We are adopting proposed Rule 203, with some modifications, after considering the comments received.53 As adopted, Rule 203(b) creates a uniform Commission rule requiring a broker-dealer, prior to effecting a short sale in any equity security, to "locate" securities available for borrowing. For covered securities, Rule 203 supplants current overlapping SRO rules. Specifically, the rule prohibits a broker-dealer from accepting a short sale order in any equity security from another person, or effecting a short sale order for the broker-dealer's own account unless the broker-dealer has (1) borrowed the security, or entered into an arrangement to borrow the security, or (2) has reasonable grounds to believe that the security can be borrowed so that it can be delivered on the date delivery is due.54 The locate must be made and documented prior to effecting a short sale, regardless of whether the seller's short position may be closed out by purchasing securities the same day.55 The rule provides for some limited exceptions, including for short sales effected in connection with bona-fide market making.

Therein lies the biggest problem. While Rule SHO attempts to limit the naked shorts, the exemptions cover those that are most likely to participate in the transactions, namely market makers and others with large $$$$ that are moving the markets. Hedge funds can also be considered market makers in some instances, as they may be part of a bigger brokerage operation.

THE SEC COMMENTS ON NAKED SHORTS:
"Naked short selling, however, can have negative effects on the market. Fraudsters may use naked short selling as a tool to manipulate the market. Market manipulation is illegal. The SEC has toughened its rules and is vigilant about taking actions against wrongdoers. Fails to deliver that persist for an extended period of time may result in a significantly large unfulfilled delivery obligation at the clearing agency where trades are settled. Regulation SHO is intended to address these effects by reducing the number of potential failures to deliver, and by limiting the time in which a broker can permit a fail to deliver to persist. For instance, as explained above, Regulation SHO requires brokers and dealers to close-out the open fail-to-deliver positions in "threshold securities" (i.e., securities that have experienced a substantial number of extended delivery failures) that have persisted for 13 consecutive settlement days."[4]

As always, a rule without consequence is nothing more than a friendly suggestion. We need to stop being so nice....

Andrew Horowitz, CFP

www.thedisciplinedinve...

Dendreon's Provenge: Looking Past The Noise

Maybe there is some confusion with this, but it does seem rather odd that Dr. Sher is so outspoken on this, especially as this therapy seems to be safe. It does seems blatently obvious to all there are many conflicting parties that are lobbying for or against on this one and more odd that it was voted to be unanimously "safe".

According to most definitions, efficacy In a medical context it indicates that the therapeutic effect of a given intervention (e.g. intake of a medicine, an operation, or a public health measure) is acceptable. 'Acceptable' in that context refers to a consensus that it is at least as good as other available interventions to which it will have ideally been compared to in a clinical trial. For example, an efficacious vaccine has the ability to prevent or cure a specific illness in an acceptable proportion of exposed individuals. In strict epidemiological language, 'efficacy' refers to the impact of an intervention in a clinical trial, differing from 'effectiveness' which refers to the impact in real world situations.

Also let's tell the whole story, the wording was changed to substantial evidence of th EFFICACY, which is, as H.S. writes, the common phraseology. The FDA uses a vague language set to ensure that they will no be held liable for a failure of an approved drug. It is their way out...By the way, a 90% historical correlation on approvals with the FDA and Advisory Panel is rather impressive. What changed?

Finally, have you noticed that there have been times that the FDA has been wrong (Vioxx as an interesting example). There is plenty of evidence that Provenge does extend life, but the primary endpoint was not reached which was to slow the growth of PC. The endpoint miss was extraordinary slight and the initial endpoint of Study 9901 barely missed tolerance of p =.052

The study clearly showed that Provenge was effective in extending life. This in conjunction with other treatments that can slow progression are a good "cocktail" that may help to slow the progression of PC and to extend life, maybe long enmough for other, yet to be discovered restatements to work.

One more point, as HS writes, there were a few conflicts that are well documented about 2 of the 4 on th panel that voted against. Scher has requested a waiver as he has an interest with the direct competitor of DNDN. He receives grants and potential stock from the DIRECT COMPETITOR OF THE DRUG HE DID NOT WANT TO APPROVE! Isn't the a concern in that.
Take a look at the waiver letter (www.fda.gov/ohrms/dock... ) for yourselves.

What would you say if we had Larry Ellison voting on whether or not Microsoft's Access database should approved for use and sale to the public? <b>Of course there is a "Slight" conflict there.</b> I do not mean to trivialize the importance of the FDA and their difficult job of protecting humans from harmful drugs like Tysabri, Vioxx....etc)

This is a MESS!!!!!! And stinks to high Hell!