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  • Pimavanserin: The Most Underestimated Blockbuster In Biotechnology [View article]
    Author is too bold.
    Pimvanserin has shown that it works pretty well in Parkinson's related psychosis. To extrapolate this result to other forms of psychosis is a big jump. Psychosis is a syndrome; and like all syndromes they tend to have some similar features but mechanisms may be quite different. Perfect examples of this are:
    -Dementia: can be caused by ischemic strokes, Alzheimer's, normotensive, subdural hematomas, etc.
    -Congestive heart failure: systolic and diastolic dysfunction heart failure have different therapy. Ischemic and non-ischemic heart failure have different therapies. Also, not every heart failure patient benefits from resynchronization, only a subset
    -Atrial fibrillation: not every patient needs cardioversion.
    -Non-small cell lung cancer: Treatment adjusts to mutations.

    I have not tried to verify the accuracy of the prevalence of cases of Alzheimer and schizophrenia. Having said this, from your numbers, roughly 1/3 of your cases would come from Alzheimer. Therefore, if Pimvanserin fails in Alzheimer, the valuation drops 1/3 in a jiffy.

    My disclosure: I don't own shares of Acadia. I would not short it either.
    Oct 14, 2013. 08:31 PM | 2 Likes Like |Link to Comment
  • Nanosphere: The Next Cepheid? [View article]
    Nanosphere presented posters at the 2013 Interscience Conference on Antimicrobial Agents and Chemotherapy. Unfortunately the posters are not available for free at the conference site (nor at NSPH). It is a bummer because in one it compared itself against the Biofire platform (for Gram-positives only). It is also a bummer because the conference was over a week ago and we haven't seen either a soar in the stock price nor the company has released poster data.

    My disclosure: I sold my NSPH shares after the last conference call. Not planning on buying until great news on performance of the test are given (Biofire is a serious competitor)
    Sep 19, 2013. 07:29 AM | Likes Like |Link to Comment
  • MannKind's Latest Data [View article]
    Regarding:
    "People might be worried about possible effects on lung function, which show up in the data (FEV1 as well as a side effect of coughing). But there are potentially even bigger concerns in the number for HbA1c and fasting glucose. A closer look at the data shows that MannKind's product may not have clearly established itself versus the injected-insulin competition"

    -As a practicing pulmonologist, the FEV1 remained stable. Cough lasted a little. No reports of shortness of breath. No reason to suspect an interstitial lung disease or that it triggers asthma. Therefore, the lung effects are not concerning. To make it even more interesting, the company has data proving that the pulmonary clearance is high, which was no tthe case for Exubera.

    -In diabetes, the main goals are HbA1c and hypoglycemia. The first has to do with long term complications of the disease. The latter is the most common complication. Fasting BG has to do with how well controlled is the blood glucose, although HbA1c is a betet rmarker, Having said this, studies done to determine if a drug works or if it has complications usually recruit great patients (those that are compliant). Many patients don't like to use insulin because of the fear of needles (even when needles are short now), No patinet likes the concept of needles (even the compliant ones), Therefore, I think that inhaled insulin will become the standard of care, unless the company decided to charge a ridiculous amount of money

    My disclosure: I sold my MNKD shares during this stock debacle. I will buy them again when the market is less choppy.
    Aug 15, 2013. 04:05 PM | 13 Likes Like |Link to Comment
  • Nanosphere's CEO Discusses Q2 2013 Results - Earnings Call Transcript [View article]
    This was not a good quarter for NSPH. The CEO acknowledged competition from the outside.
    Aug 7, 2013. 07:46 AM | Likes Like |Link to Comment
  • Durata Therapeutics' Novel Antibiotic Makes It A Prime Takeover For 2013 [View article]
    The company posted NO significant electrocardiographic changes (prolonged QT) on its abstracts.
    NO idea on diarrhea
    Jul 31, 2013. 11:17 AM | 1 Like Like |Link to Comment
  • Durata Therapeutics' Novel Antibiotic Makes It A Prime Takeover For 2013 [View article]
    Three things are important regarding Dalbavancin:
    -Efficacy: It has it
    -Great pharmacokinetics: It has it
    -Does not get inactivated by surfactant. http://bit.ly/15aMtum
    This last one is the big difference if Cubist's daptomycin and creates a real window for pneumonia. On the contrary, daptomycin gets inactivated by surfactant and is contraindicated in pneumonia.

    My disclosure: I don't have shares of this company but I likely buy them soon
    Jul 31, 2013. 08:18 AM | 1 Like Like |Link to Comment
  • Exact Sciences - Cologuard Is Strike 3, And EXAS Is Out (5 Of 5) [View article]
    Most MDs don't play the stock market because of different reasons. Because of the nature of the profession, they all wait for published data.
    The test appears to work. Like all screening tests they need to be cheap enough and easy to do. Cologuard meets conditins 1 and 3. If the company charges $1000 a test it will not sell. If it charges $100-300 it will sell.
    Jul 31, 2013. 01:05 AM | Likes Like |Link to Comment
  • Exact Sciences - Cologuard Is Strike 3, And EXAS Is Out (5 Of 5) [View article]
    I wonder if the author of this article has ever used a pill cam.
    -It needs a great colonic preparation. Experience from colonoscopies say this is not always the case, and this is considering that colonoscopes can make do some cleaning by injecting water.

    -It requires one trained technician or physician to dedicate quite a bit of time to view the images. This means either losing money in paying a tech salary or not seeing patients directly.

    Virtual colonoscopy:
    Virtual reconstructions of CT are only OK. I do navigational bronchoscopies and have to work with the virtual reconstruction of the trachea and bronchi. Reconstructions are just OK and have difficulties interpreting lumps. This does not even consider radiation dose. At the end of the day live colonoscopy is superior to virtual colonoscopy
    Jul 30, 2013. 05:29 PM | Likes Like |Link to Comment
  • K-V Pharmaceuticals - One Of The Best Risk/Reward Scenarios You'll Come Across [View article]
    KV Pharmaceuticals is selling and has gotten it's act together. My concern about this stock comes from a recent article on thestreet.com
    http://bit.ly/12YDqap

    Of note, journalists at TST are not allowed to own stocks other than TST, which limits bias
    My disclosure: I sold my KVPHQ shares some days ago.
    Jul 29, 2013. 05:55 PM | Likes Like |Link to Comment
  • Exact Sciences - Line Your Pockets, Not Your Toilet Bowl (3 Of 5) [View article]
    You have to try 1 gallon of Golitely + having an entire night of diarrhea to understand what colonoscopy preparation means. Having said this, to get a colonoscopy takes quite a bit of time from the MD and patient perspective.

    a) Clerk has to find a gastroenterologist that will take the patient's insurance
    b) A colonoscopy might take 10 minutes + roughly 1-2 hours post anesthesia supervision. This limits the number of colonoscopies an MD can do. Gastroenterologists also have clinic and inpatient duties.
    c) After a colonoscopy, the day is blocked for that patient (because of remaining sedative effects).
    Jul 27, 2013. 09:54 PM | 1 Like Like |Link to Comment
  • Exact Sciences - Line Your Pockets, Not Your Toilet Bowl (3 Of 5) [View article]
    Nobody says that it will replace it. But it is very easy to see it as competing with a colonoscope for diagnosing malignancy (90%+ effective). At the end of the day an MD does not like uncertainty and FIT is much more uncertain.

    Regarding stool collection. EXAS provides you the bucket in which the patient directly poops. Bucket is taken out and sent directly to company; very simple (unless patient is quite crippled like from dementia or stroke). Most 50+ years old should find it easy.

    I have seen MDs do guaiacs many many times after a DRE in Atlanta, San Diego, Milwaukee and now in Miami. Why not take advantage of the moment? It is not as effective but quite more than never doing any testing at all.

    @jhugard:
    The author from the Barron's article you posted does not mention his bibliography (this is VERY important). It would be nice to know how he knows 10 million kits are sold annually. Assuming that data is accurate, 10 million screened patients is much less than the 80 million people they say are candidates for screening. Having said this Barron's math might be off. According to the 2010 US Census Bureau, the population over 50 is at least 99 million, which creates a bigger market for any cancer screening technique (http://1.usa.gov/rO2tOW table 2)
    Jul 27, 2013. 09:45 PM | 1 Like Like |Link to Comment
  • Exact Sciences - Line Your Pockets, Not Your Toilet Bowl (3 Of 5) [View article]
    From a physician's perspective. The main limitations for cancer screening are poor patient compliance and poor testing performance. Regarding FIT vs Cologuard:

    a)Physicians do not like uncertainty. When a physician diagnosis cancer he wants it to be early stage, not advanced. FIT sensitivity depends on the patient bleeding as FIT detects globin. Cancers do not bleed all the time and therefore yearly samples are required. Cologuard detects DNA which explains it better performance. American Cancer Society and American Gastroenterological Association will love it.

    b) Collecting a sample of stool and delivering it is an uncomfortable process. FIT and FOBT requiring scraping stool in the toilet bowl; Cologuard doesn't (patient poops directly).

    c) As a pulmonologist I have seen MANY colonoscopies in the intensive care unit (for life-threatening gastrointestinal bleed). I can not recall a single patient being enthusiastic about having their rectal vault invaded (even under moderate sedation).

    Cologuard will not be marketed as replacing colonoscopies. I SUSPECT it will be marketed as having a 90%+ detection rate which will be seen by MDs as comparable to colonoscopy. EXAS will market it as very easy to do (1 sample) and that the company will make great efforts trying to get the patient to send the sample. What better screening service for MDs:
    -It makes an early solid diagnosis
    -Less work for the clerk/assistant making sure sample gets done.
    -MD does not have to find a gastroenterologist that takes Medicaid (some will not take plain Medicare) for routine colonoscopies

    My disclosure: I have EXAS shares. I thank the author for his articles because he if he is successful I will buy more EXAS shares at a cheaper price
    Jul 27, 2013. 07:45 AM | 3 Likes Like |Link to Comment
  • Nanosphere: There's Gold In Its Diagnostic Tools [View article]
    I am surprised that BioFire's panel did not evaluate for Staph epidermidis, the most common cause of a positive blood culture (and most common contaminant). I am not a microbiologist but this should not be difficult to obtain as they already identify so many Gram positive organisms.

    BioFire is a private company that is a serious challenger to Cepheid, Nanosphere and Meridian Biosciences. For the sake of Nanosphere, I hope the Gram negative resistance panel that they evaluate is much more complete.

    My disclosure: I own NSPH shares
    Jul 7, 2013. 06:28 PM | Likes Like |Link to Comment
  • Regeneron's New Asthma Drug And Its Fierce Competitors [View article]
    Anaphylactoid reactions can happen at any moment. Depending on the drug you can give some pre-medication with IV steroids. In asthma , this would defeat the main purpose of avoiding IV steroids.

    Don't worry about it right now. Lets wait for data
    Jun 30, 2013. 02:39 PM | Likes Like |Link to Comment
  • Regeneron's New Asthma Drug And Its Fierce Competitors [View article]
    Paper published in the New England Journal of Medicine was quite interesting. Patients had an average FEV1 70% +/- 12% predicted while on adequate medication. They were a moderate asthma group whose symptoms were not controlled, making it an adequate group to study the effects of any drug (patients were not too sick, nor too healthy). Study group had symptomatic, biologic and physiologic improvement.

    Main limitations of the study:
    -Sample size was determined by what is the chance that treatment will reduce the number of exacerbations. Exacerbation rate was defined by a 30% decrease in the peak flow (not as good as FEV1), increased need for albuterol, need for oral/IV steroids or need for hospitalization. The large difference in the primary outcome (6% vs 44%) was made up by change in peak flow or need for albuterol. In my eyes of a practicing pulmonologist, these are just soft outcomes. I would have preferred that the sample size would have been powered to need for oral/IV steroids and just FEV1 (like most large asthma studies). This would have made the study larger, longer and more expensive.

    Will this be a blockbuster drug if a subsequent study repeats similar results:
    -Only 20% of those screened were eligible for study. Asthma is a disease that has many causes and works in different ways. As times pass it is becoming more like a syndrome. Because of this, investigators ONLY included patients with a high number of eosinophils in blood or sputum. Dupilumab will probably compete with Xolair (Abbvie Labs) which is an anti-IgE antibody.
    -Will it work on asthmatics that do not have high eosinophils?
    -Safety issues? Drug appears safe in 104 patients.... but so did Xolair, which is injected and can cause a rare severe anaphylactoid reaction.

    Phase 3 data will confirm what appears to be a nice new drug. I would not buy Regeneron based on THIS drug based on THIS study, unless a larger phase-2 study is done which suggests the drug works.
    Jun 30, 2013. 11:37 AM | 1 Like Like |Link to Comment
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