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Joseph Krueger

 
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  • Sanofi-Aventis Seeks the Holy Grail of Insulin [View article]
    I have repeatedly recieved private emails from diabetics saying they would never use inhaled insulin. As well, spend some time reading message boards for diabetics- many posters state they would not use it either. Perhaps marketing can solve this bias against inhaled insulin, but for now many diabetics are not comfortable with this idea. Definitely many diabetics will also embrace it, but my impression from reading these types of message boards is that although not ideal, most diabetics do not mind using needles; it is something they are used to. What they really want more than anything is better and more convenient glucose control at meals and less hypoglycemia between meals. Products like Afrezza and Linjeta offer that. Let the diabetics choose if they want inhaled or injected insulin.
    Sep 28 09:05 AM | 3 Likes Like |Link to Comment
  • Sanofi-Aventis Seeks the Holy Grail of Insulin [View article]
    You are correct, they are phase II, not phase III trials, with Novolog and Humalog. I have submitted statement for the correction.
    Sep 28 08:45 AM | 1 Like Like |Link to Comment
  • Sanofi-Aventis Seeks the Holy Grail of Insulin [View article]
    As far as when SNY would partner, they stated they are seeking to announce such partnerships "in the next few months". This would seem to be after PDUFA. This also makes sense- although the partnership would be more expensive their would be no hurdles to move forward. If you look at past partnerships with other companies (in general) partners are often willing to pay more for a "sure thing". If Linjeta approval is denied/delayed then maybe they can still get in "on the cheap".
    Sep 27 07:56 PM | 2 Likes Like |Link to Comment
  • Sanofi-Aventis Seeks the Holy Grail of Insulin [View article]
    As mentioned, NVO is losing exclusivity of Novolog in 2011, so they would benefit from a new fast-acting insulin. But SNY is the obvious choice as Linjeta is the only known insulin product compatible with Lantus. The combination product fills the gaping hole Lantus has in the diabetes market right now. Lantus global sales are said to approach $6 billion a year by 2014- you can imagine that SNY needs to replace those sales when Lantus goes generic, and Linjeta could be the key to protecting significant sales.
    Sep 27 07:53 PM | 1 Like Like |Link to Comment
  • Sanofi-Aventis Seeks the Holy Grail of Insulin [View article]
    Pacard, the 6.5% was just an assumption made for revenue calculations. As you know, RHI is pretty damn cheap. Both MNKD and BIOD have to so some simple chemistry (although Afrezza has to be lypholized to be inhaled but no big deal) to turn it into their respective drugs. So I don't thing manufacturing costs are going to be significant whatsoever for either product.
    My margins comment pertains to the fact that MNKD has spend nearly 10X more than BIOD on development costs, and those costs need to be recouped in partnership payments and revenue. As well, marketing costs and post-approval monitoring costs. As well, both products need to be competitive with existing prices of other "similar" products.
    In light of this, I think a partnership with MKND would have to be much more costly than BIOD for the partner to see a good ROI.
    Sep 27 07:23 PM | 1 Like Like |Link to Comment
  • Biodel's Linjeta Should Overcome the Usual FDA Approval Hurdles [View article]
    make that "hedge longs with puts", oops.
    Sep 26 10:03 PM | 1 Like Like |Link to Comment
  • Biodel's Linjeta Should Overcome the Usual FDA Approval Hurdles [View article]
    If anything, we have all learned that the FDA is unpredictable. Make sure to hedge your longs with some calls, or only risk what you are willing to lose. Although I am convinced that investors are missing the boat, I am sticking to my investment rules with BIOD and will only invest a percentage of my portfolio that I can stand losing in the worst case scenario. Too many ARNA longs were so convinced it was such a sure thing they were betting the farm on it. Obviously investors are less sure about BIOD, and have priced in a better chance of failure then success, but that is what makes its reward so great for BIOD longs.
    Sep 26 10:03 PM | Likes Like |Link to Comment
  • Biodel's Linjeta Should Overcome the Usual FDA Approval Hurdles [View article]
    Just a wild guess:
    If an "approvable" CRL were to happen, I would expect a 40% initial drop in price, followed by relatively quick recovery as investors absorb that this means the "Indian data" debaucle is not a problem, and whatever minor issues arose are easily fixed and will not delay the expected Linjenta pen delivery launch in mid-2011. The price might even go higher as more investors realize that Linjeta WILL get approved soon. I am prepare to heavily add to my BIOD position on the drop if this were to happen.
    Sep 26 03:40 PM | Likes Like |Link to Comment
  • Biodel's Linjeta Should Overcome the Usual FDA Approval Hurdles [View article]
    Shorts are just as greedy as longs. Longs don't know when to sell and shorts don't know when to cover. Perhaps they cannot cover at these low prices, and are risking that bad news in October will give them a chance. Perhaps they are ignorant of the details we are discussing here and don't see much risk in holding short positions given the "failure" rate of pivotal FDA approvals. BIOD is a risky long position (although no more risky than any other pivotal FDA position-and I am arguing that it is even less so), but I don't know how shorts can tolerate the risk here with approval looming. Even a CRL that said anything besides "run two more years of trials" would be positive, as this is what is being priced in right now.
    Sep 26 11:52 AM | Likes Like |Link to Comment
  • Biodel's Linjeta Should Overcome the Usual FDA Approval Hurdles [View article]
    actually mark_sensing there are both posters in that PDF....look on the next page for the type 1 results with the Indian data excluded. There has never been a problem with the type 2 study, the problem was always unique to the type 1 study. The link you provided provides much more detailed information on the type 1 study in regards to the Indian data...see my comments below.
    Sep 25 07:49 PM | Likes Like |Link to Comment
  • Biodel's Linjeta Should Overcome the Usual FDA Approval Hurdles [View article]
    Thanks again for this link.
    Actually, it appears that the problem with the Indian samples were in the control arm...as both Linjenta arms were identical in US+Germanay and India. The RHI group showed an astounding -1.09HhbA1c decrease in the study- this is actually medically impossible for RHI. They also demonstrate that the way the samples were handled (ovenight to central lab vs local handling) affected the HbA1c readout. I find it hard to accept that the FDA scientists would look at the RHI group from India and believe that those patients indeed saw a -1.09 decrease in HbA1C. No other non-inferiority study for fast acting insulin vd RHI has ever seen those kinds of numbers... I think BIOD has a pretty convincing case that the samples were indeed flawed.
    Sep 25 07:45 PM | Likes Like |Link to Comment
  • Biodel's Linjeta Should Overcome the Usual FDA Approval Hurdles [View article]
    according to the poster there was about 180 patients in earch arm of the type 1 study, so those numbers make sense.
    Sep 25 07:32 PM | Likes Like |Link to Comment
  • Biodel's Linjeta Should Overcome the Usual FDA Approval Hurdles [View article]
    THIS IS SPAM
    Sep 23 08:49 PM | Likes Like |Link to Comment
  • Biodel's Linjeta Should Overcome the Usual FDA Approval Hurdles [View article]
    There was still 140 patients in each arm of the type 1 trial. There were about 180 patients in each arm of the type 2 trial. My understanding is that both trials attempted to enroll about 200 in each arm. So they excluded about 80ish samples from the type 1 trial, 40 each both control and Linjeta arms. This number is consistent with the stated sizes of the Indian trials. The fact that they excluded controls as well as Linjeta patients from the Indian data is consistent with the idea the samples from that arm were mishandled- both control and Linjeta. Why would Linjeta not work in type 1 diabetics from India but work fine in the US and Germany; and Linjeta work in type 2 diabetics in all three sites, unless there was a specific set of samples that was flawed?
    In my mind, the case for proving that the type 1 Indian samples were flawed is proven. The type 1 trial size is only about 20% smaller than the type 2 trial. In both cases, they proved non-inferiority, and the patient numbers should be sufficient to prove this (or they wouldnt be statistically significant).
    I don't think the FDA will have a hard time buying this....it is insulin, they know it works, its safety profile is well understood, the whole concept is very straightforward.
    Sep 22 06:13 PM | Likes Like |Link to Comment
  • Arena’s Lorcaserin: What Now? [View article]
    The first type screening a compound goes through related to this is the Microsome Reverse Mutation Assay (Ames test), which quickly identifies compounds that have mutagenic capability. Anything that fails this has no hope (exception: some chemotherapuetic drugs which actually damage DNA and can cause cancer in the long term).
    Long-term carcinogenicity studies in rats are designed to identify non-mutagenic events that contribute to cancer- these are known as cancer promoters. For this, they use rats which are obviously pre-disposed to cancer (as seen in the control group) and expose them to extremely high levels of drug for a good length of their lifetime. The doses chosen are based on high exposure multiples- in other words doses that are known to be well above the dose expected to be used. in the "real world" in certain multiples.

    Since cancer takes 10-20 years to develop in humans, these studies are designed to condense 20 years of human life into 2 years of rat life. To accomplish this, they have use very high doses of the drug. A basic pharmacological principle is that drug exposure= dose over time. A small dose over a long time is pharmacologically equivalent to a large dose over a small time (at least in principle). So they use a large dose over a small time in place of a small dose over a large time. That is the rationale for the way these studies are done- it is in fact scientifically questionable, but it is the best we have.
    Scientists can argue back and forth about whether or not the rat model is an appropriate model....in fact ARNA tried to do that. The FDA knows to take these studies with a grain of salt, as the "reality" behind them is scientifically questionable. But in this case it has to do more with the intent of the studies rather than their actual scientific value. The intent of the rat studies is to show that there is absolutely no activity in the rat carcinogenicity model. ARNA could not do that. This result suggests that a low dose of Lorcaserin over a long time could promote cancer. Given how Lorcaserin would be intended to be used, this is in fact relevant.
    The FDA has to weigh the "real world" value of these study results against the benefits. In the case of some chemotherapuetic drugs, risking giving someone cancer 20 years down the road to save their life right now is worth it. Some drugs with good benefit are used for short periods of time (like antibiotics) and thus a positive rat test would be tolerated. In the case of a drug that barely helps someone lose weight, and is designed to be taken for long periods of time, almost any cancer risk is too great.
    Clearly that is the FDA's take on it. I doubt that ARNA could do any studies that would change this perception. But they do need to try...there are examples of drugs that have failed the rat test which eventually got approval. Sometimes the FDA just needs persuading.
    I hope this helps.
    Sep 22 03:55 PM | 4 Likes Like |Link to Comment
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