From p. 3 of this story:

http://houston.bizjournals.com/houston/stories/2006/12/25/story5.html

"At that time, Efficacy Capital Ltd.'s Mark Lappe told BusinessWeek magazine that "it's likely (that) the likes of Pfizer or Wyeth will buy Zonagen."

Efficacy Capital, which invests mostly in biotech firms, owned a 9.9 percent stake in Zonagen as of December 2005."

They are expecting a buyout and continue to build their position.

Approval could come any day now. It's hard to believe it's down so much on a downgrade based on delays that are almost over. I'm adding here.

> In other words, there will be a lot of sound and fury that will ultimately prove to be of no real consequence.

Yes, and DNDN will never submit their Provenge BLA ...

To get to the root of it - Pazdur.

> Notably, the congressmen are asking for a probe into the makeup and conduct of the Provenge advisory panel rather than a probe into the FDA’s review of the BLA per se. This strongly suggests that the probe will have no material impact on the probability that Provenge will ultimately be approved.

That seems to put an undew negative spin on things. What are consequences if the investigation finds that conflicted panel members were selected by Pazdur and purposely derailed the approval of provenge. Wouldn't the FDA be obligated to review the decision and, perhaps, reverse that decision? Stop trying to piss on DNDN investors Corn Flakes.

Michaud Calls for Hearing on Potential Life-saving Prostate Cancer Drug

http://www.arighttolive.com/

FOR IMMEDIATE RELEASE

December 13, 2007

CONTACT: Monica Castellanos @ 207-782-3704

Michaud Calls for Hearing on Potential

Life-saving Prostate Cancer Drug

WASHINGTON, DC – Today, Congressman Mike Michaud joined with his colleagues Congressman Dan Burton (R-IN) and Tim Ryan (D-OH) in calling on the House Energy and Commerce Committee to conduct a hearing to examine the conflict of interests governing the Food and Drug Administration (FDA) and its recent decision on failing to approve licensure of Provenge, a potentially life-saving therapy for those suffering from advanced prostate cancer.

“Many ethical questions remain about the two panelists who voted no on approving this drug,” Michaud said. “I believe that the FDA should not be appointing scientists leading the testing of a rival drug for another firm onto an advisory committee evaluating Provenge. Congress needs to get to the bottom of this. I believe a full disclosure is necessary in order to restore confidence in the FDA.”

The bipartisan letter requests that the Energy and Commerce Committee hold a hearing to examine possible ethical violations of these panel members considering the viability of potentially important life-saving drugs.

“We need to ensure that the FDA gets life-saving drugs to the market as quickly and as safely as possible,” Michaud stated. “Our priority is to ensure the prompt and efficient approval of therapies such as Provenge that could potentially benefit millions of Americans with cancer.”

You should get another 7 days for posting that message. Ah hell, let's make it permanent. Stop the childish insults and you'll be treated like an adult.

Volume is drying up. Looks like the big seller(s) are about finished. Up we go again?

>>With all due respect Dew, that sounds kinda like a Jonathan Aschoff report on DNDN.<

>Aschoff’s predictions on DNDN have turned out to be more accurate than the predictions of 95% of message-board posters, so I’ll take your remark as a compliment.

Well, considering that most of my market gains this year were from DNDN, I'm rather glad I didn't listen to him. And wasn't it you that suggested DNDN would never submit their BLA, nevermind get an overwhelmingly positive AC panel vote. Anyway, I don't want to get into a pissing match - so I'll stop there. Re. RPRX, I'm merely suggesting that something beyond intuition or smell should be your basis for slamming a stock. Back your opinion with legitimate arguments and I'll listen.

With all due respect Dew, that sounds kinda like a Jonathan Aschoff report on DNDN. Chuck all the mud that you can at em and pray to God that something sticks. There's absolutely no evidence to suggest that JP is being untruthful - just some female-like intuition. That's just not good enough.

PS - for BSR subscribers, I thought Miller explained away the IND FUD perfectly

> Quiz: Name two drug companies that have directors or executive officers who used to work for Pepsi.

Bruce Colwill is CFO at Neuromed
Peter Kellogg is CFO at Biogen

Both used to work at Pepsi.

Hmmm, I do smell something. And it reminds me of manure.

BSR alert out. Very nice reading.

>What reason was given?

Dunno. Don't even remember when/where I heard that guidance. But I'm fairly certain I did.

Looking at the slide below (from the 11/05/07 8K), I see that the # of pts required in the fibroid study is more than anticipated. Still scratching my head over the 20% haircut though.

RPRX management had already provided guidance that a new IND would be required for the anemia indication. Today's selloff was nothing more than short-sighted hedgies unloading. A good opportunity for those without a position or wanting a bigger one to get shares at bargain prices. I think it'll bounce back fairly quickly, unless there's something that retail doesn't know about.

Anybody care to guess when we'll get a PR on the outcome of today's meeting? I gather that the board needs to OK such a release and that this one is more complex than the androxal endpoint meeting. I'd expect something by mid-week, maybe before Monday's bell. Has anybody been in touch with JP this afternoon?

Every board seems to have one these scumbags eh? While I'm all for the open expression of both bullish and bearish viewpoints, mindless pumpers and bashers (like y3maxx) should be purged by the moderators. JMHO.

I've been watching PP since BSR brought it to my attention several weeks ago. That photo of the CEO being dragged out of the DORB advisory committee meeting was enough to prevent me from establishing a position. What was he thinking?

I'm starting to do some DD on this stock and can't find an explanation for the shareprice dropping from $16.53 on Feb 13 '07 to $4.05 the next day. Anybody care to help out? TIA

Apparently so. The CEO of a pre-earnings biotech is supposed to hype his stock. When a widely-read and "neutral" analyst does the same thing, the stock reverses direction. I just wish the CEO would get this stock into stronger hands.

Yes, it was positive - very positive. It seems to have soothed the nervous nellies.

How does a metabolic endpoint like blood glucose levels become a swing for the fences?

FWIW, I loaded up today at a price I thought I'd never see again.

I think y3maxx was being sarcastic i.e. having a bit of fun at Nerf's expense.

I am very surprised at the drop in shareprice, even considering the overall market sentiment. A $2 drop in one week following a positive news event is excessive. The only other events have been JP's two presentations. In these he covered the uncertain androxal endpoint situation (a different spin on the more positive post FDA meeting PR) and raised the issue of future financing. I don't see any other explanation for the price drop.

WAG 11/17/2007 1:25 PM

They shouldn't be given credit for anything. They should be ridiculed for doing the worst marketing job in pharma history. Disclosure - I do not own stock in PFE or any other company associated with inhaled insulin.

Your losses are yours alone. Take responsibility for your investment decisions and stop trying to pin it on someone else. I've read about 5 of your messages on multiple boards whining about this.

PFE seems to confirm that they blindsided NKTR:

"Because of Securities and Exchange Commission rules we could not reach out to them until this morning, which we did," said Pfizer spokesman Andy McCormick.

McCormick said Pfizer withheld the news from Nektar until then because it was "material information" related to Pfizer's quarterly earnings.

http://www.reuters.com/article/marketsNews/idUKN1828702220071018?rpc=44

Any BSR subscribers here? Any idea where the bottom will be? I've been watching and waiting for a good entry point.

Yes, you are right, I forgot about SNY. Anyway, the point I was trying to make was that PFE didn't know the market and is largely responsible for this failure.

While I don't think Exubera ever had the potential to be the blockbuster that many suggested, it certainly should have done better than it did. Responsibility for that, IMHO, lies squarely with PFE - they constantly delayed the launch and then did a piss poor job of marketing it. I never understood why NKTR went with PFE - they have no experience with diabetes. NVO would have been a much better partner.

I assume that PFE will also be abandoning their collaboration with NKTR on the development of Exubera II (a smaller device). And what will NKTR do with Exubera once PFE has returned the rights. Look for another marketing partner? This doesn't sound like it: "New York-based Pfizer said it would return its worldwide Exubera rights to Nektar and work with doctors over the next three months to switch Exubera patients to other diabetes treatments." How could PFE have got it so wrong? Wow.

> Did they file the NDA yet, weren't they supposed to have done so by now?

November 2007