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Joseph Krueger

 
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  • 30 Critical Housing Charts That Investors Must Consider [View article]
    The greatest global economic expansion in the history of the world has taken place in the last 60 or so years, accelerating dramatically in the last 20. What was generally true for the last 120 years is not true anymore...simply put, things are different now. Look at a normalized P/E ratio for the Dow since 1929:
    1.bp.blogspot.com/-SG9...
    You will notice 3 things:
    1) It has wild swings;
    2) It is somewhat cyclical; and
    3) It is in a general uptrend for the last 60 years, as global wealth has increased.
    Now apply this to Case/Shiller: All these 3 things are true.
    In other words, don't expect home values to ever return to a historic average, as this has changed with the increase in global wealth. Home values may drop some from here, but don't expect them to return to the 120 year average.
    May 30 08:26 AM | 2 Likes Like |Link to Comment
  • Will Orexigen's Diet Pill Survive an FDA Panel? [View article]
    Buproprion and naltrexone as individual drugs (Contrave) have a far superior safety profile than phentermine and especially topiramate (Qnexa) as individual drugs. Based on the FDA's change in opinion about weight loss drugs, a negative Qnexa vote was far easier to guess than a negative Lorcaserin vote. But being a new chemical entity with marginal efficacy Lorcaserin had higher hurdles than the generic combos, so it seemed unlikely also. For me, Contrave offered the right balance of safety and efficacy the FDA was looking for. Against 90% of general opinion, I predicted that Qnexa and Lorcaserin would have a negative review/be rejected and that Contrave had the best shot. I said that back in July.
    seekingalpha.com/artic...
    Now with the benefit of hindsight, the reasons why seem obvious. Contrave isnt out of the water yet, but it is clear that it offers the risk/benefit profile the FDA is looking for. The only hurdles to its approval are labeling, and agreement on post marketing studies.
    Dec 8 09:33 AM | Likes Like |Link to Comment
  • Orexigen's Contrave Receives Panel Backing: Great News for Vivus [View article]
    Buproprion and naltrexone as individual drugs (Contrave) have a far superior safety profile than phentermine and especially topiramate (Qnexa) as individual drugs. Based on the FDA's change in opinion about weight loss drugs, a negative Qnexa vote was far easier to guess than a negative Lorcaserin vote. But being a new chemical entity with marginal efficacy Lorcaserin had higher hurdles than the generic combos, so it seemed unlikely also. For me, Contrave offered the right balance of safety and efficacy the FDA was looking for. Against 90% of general opinion, I predicted that Qnexa and Lorcaserin would have a negative review/be rejected and that Contrave had the best shot. I said that back in July.
    seekingalpha.com/artic...
    Now with the benefit of hindsight, the reasons why seem obvious.
    Dec 8 09:31 AM | 1 Like Like |Link to Comment
  • Mannkind's Afrezza Seems Short of Breath [View article]
    This is why people follow me- I understand the science, study the regulatory policy of the FDA, and I make tough calls. Nearly 6 months ago, well against most analysts and general opinion, I said in detail accross two articles that VVUS and ARNA would fail, and OREX would prevail. Check the OREX news today- I look to be right on all three accounts.
    seekingalpha.com/artic...
    Dec 7 05:16 PM | 2 Likes Like |Link to Comment
  • Arena's Weight Loss Drug Faces Relatively Easy Path to Approval [View article]
    Still no improvement in efficacy now we have to worry about heart safety!
    www.bloomberg.com/news...
    Nov 9 08:15 PM | 1 Like Like |Link to Comment
  • 4 Biotech Clearance Rack Stocks [View article]
    If anyone would know, you would think it would be a person in that position. Employees at that level only get fired for three things: gross misconduct, gross incompetence, or whistle blowing. We know it is not incompetence because we hear so often about how well the trials are going. If it was misconduct then it is a confidential issue that will have to come out in court. If it was whistle blowing, that will come out in court as well. It will be interesting to see if there is a settlement to sweep this under the rug. I don't think that this will trigger any skepticism by the FDA, but I am sure the MANNiacs will find a way to call this a hedge fund consipracy.
    Nov 5 01:01 PM | Likes Like |Link to Comment
  • 4 Biotech Clearance Rack Stocks [View article]
    Well it looks like Afrezza may be facing trouble for data fraud.....those are the allegations from a former employee.
    www.thestreet.com/_yah...
    Nov 4 03:55 PM | Likes Like |Link to Comment
  • Biodel's Linjeta Should Overcome the Usual FDA Approval Hurdles [View article]
    To all the commenters who have left abrasive messages all over my articles, let me take away the fun for you and openly admit the obvious that I called this one wrong.
    Although I was prepared for a CRL in some form, I am genuinely surpised at the severity of the CRL. It is clearly time to go back to the drawing board, it will be at least 2 years before they can submit the NDA again. I am sure there will at least be some modest dilution.
    However, this situation has erased all uncertainty, and although the clarity it provided is not ideal, it does set out for a clear plan of action for BIOD.
    I think they will be able to get a partnership soon with their suitors. Although the phase III trials are worthless, they clearly provided significant evidence that Linjeta works. With this evidence, BIOD can run the new trial with its final formulation and the injector pen, and it should be a slam dunk this time. Partners know this, and will likely be willing to fund the phase III trials.
    For me, I will be buying a nice size chunk of BIOD here and forget about it. Management and investors suffered the consequences of their inexperience and ill advice by consultants in the face of an exceptionally hostile "new FDA". They will get it right the second time.
    Nov 2 09:42 AM | 1 Like Like |Link to Comment
  • Biodel's Linjeta Should Overcome the Usual FDA Approval Hurdles [View article]
    They demonstrated that all the different formulations work equally.

    files.shareholder.com/...

    files.shareholder.com/...
    Oct 27 02:39 PM | Likes Like |Link to Comment
  • Biodel's Linjeta Should Overcome the Usual FDA Approval Hurdles [View article]
    They demonstrated bioequivalency in mini-pigs, which are an acceptable non-rodent higher mammal for PK studies. They also demonstrated its use in about 45 human patients. Would they want to see more data? I have no idea; but to me it seems straightfoward and unecssary.
    Oct 26 09:44 PM | Likes Like |Link to Comment
  • Biodel's Linjeta Should Overcome the Usual FDA Approval Hurdles [View article]
    It has always been a question of when, not if. We know that not all the I's are dotted and the T's crossed. There is plenty of good reason to think the FDA would logically see through that, especially since we are talking about insulin, but the FDA's actions seem exceptionally unpredictable as of late.
    Oct 26 09:42 PM | 1 Like Like |Link to Comment
  • Biodel's Linjeta Should Overcome the Usual FDA Approval Hurdles [View article]
    Sorry, I meant "I would guess that a "no suprise" CRL should shed about 50%"
    Oct 26 09:40 PM | Likes Like |Link to Comment
  • Biodel's Linjeta Should Overcome the Usual FDA Approval Hurdles [View article]
    October has been a horrible month for 505b2 approvals.
    Recent actions by the FDA suggest that they won't tolerate any "sloppy" work. There is apparently significant slop in the Linjeta NDA, with clinical trial inconsistencies, changing formulations and delivery, etc. Management has also been uncharacteristically quiet about the follow up data and correspondence with the FDA. Short interest has gone up 25% in the last 2 weeks with 4.7 million short, an all time high. They may in fact have it right this time, but a CRL should provide a clear path to approval.
    Of note, the last approval of a fast acting insulin (Aprida) had alot of problems. The correspondance with the FDA can be found here:
    www.accessdata.fda.gov...
    Aprida is NDA 21-629.
    In particular, see pages 15-16 46-47.
    Also see page 46, comment 1:
    Aprida study 3001 had problems with the HbA1c levels- what they called an "imbalance" at baseline. The FDA asked for an explanation of the data.
    Also see page 18- Aprida had twice as many hypoglycemia events as control.

    Novolog, the first fast acting insulin, was approved for both indications even though it didnt have a type 2 diabetics study. The novolog study was very sloppy- lots of data missing, very few subjects, plenty of hypoglycemia....but of course it was 1999 and the FDA was a different beast
    www.accessdata.fda.gov...

    But it goes to show historically, the FDA says "it is insulin! it is safe and effective!", so Linjeta has that on its side. But the bears also have a strong case. What is sure is that a "surpise" approval will send it skyrocketing; I would guess that a "no suprise" approval should shed about 50%. There are lots of buyers waiting to pick up BIOD after the CRL, so I dont expect the price to go too low.
    Oct 26 06:01 PM | 1 Like Like |Link to Comment
  • Biodel: Upside from Potential Linjeta Approval [View article]
    From their SEC filings:
    yahoo.brand.edgar-onli...

    "Update on VIAject® Formulation
    Since completing the pivotal Phase 3 clinical trials, the company has developed other formulations of VIAject® and successfully bridged from the pH 4, 25 IU/cc, two-vial lyophilized formulation used in the pivotal trials to a pH4, 100 IU/cc liquid formulation. Recently, the company successfully bridged to a pH 7 100 IU/cc liquid formulation upon which the NDA for VIAject® will now be based"

    So the new formulation is a one-part liquid.

    Here is a presentation on the U100 pH7 formulation:
    files.shareholder.com/...
    Oct 26 05:45 PM | Likes Like |Link to Comment
  • Arena's Weight Loss Drug Faces Relatively Easy Path to Approval [View article]
    Gaucho you are the man who called for a unanimous positive panel vote and easy approval. Anyone who listened to you lost of money. Anyone who listened to my "FUD" about potential toxicities and lack of efficacy is doing well.
    Oct 26 03:49 PM | 2 Likes Like |Link to Comment
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