@dsobek @adamfeuerstein Adam - still waiting on your take on the $MNKD data— Patrick Crutcher (@chasingthealpha) August 20, 2013The Afrezza data, as disclosed by MannKind ( MNKD - Get Report) last week, are: 1. Mediocre. 2. Incomplete. 3. "Positive" if one defines the term only as a drug that technically meets a study's primary endpoints but with data that are neither exciting nor groundbreaking. (See: Mediocre.) 4. Barely approvable, but only if 1) MannKind isn't hiding additional negative data, or 2) FDA doesn't give a crap and simply wants Al Mann to go away. (See: Incomplete.) 5. Insufficient to support MannKind's $1.7 billion market value. (Add in debt, options, warrants and restricted stock, MannKind's enterprise value is a voluminous $2.7 billion.) In the AFFINITY-1 study of Type 1 diabetics (also known as Study 171), Afrezza delivered via the second-generation "Dreamboat" inhaler was numerically inferior to Novo Nordisk's ( NVO) Novolog in terms of A1c reduction, the study's primary endpoint. (-0.21% vs. -0.40% A1c reduction.) The upper end of the confidence interval for the difference between Afrezza and Novolog was 0.36%, which didn't exceed the 0.40% difference that would have caused the study to fail. Therefore, MannKind can claim Afrezza Dreamboat is statistically non-inferior to Novolog -- hence a "positive" study -- but just barely. Afrezza Dreamboat performed worse than Novolog in terms of the percentage of Type 1 patients achieving A1c levels of less than 7% or 6.5% -- important markers of glucose control. Afrezza demonstrated a numerically lower severe hypoglycemic event rate than Novolog but the difference was not statistically significant. MannKind didn't disclose exact numbers. An important goal of the AFFINITY-1 study was to demonstrate equivalence between the new Dreamboat inhaler and the older Medtone inhaler. Here, MannKind is being very opaque about results, stating only that the two devices were "comparable" with respect to lung function, as measured by FEV1. MannKind did not disclose any efficacy results from the Medtone arm of the study. The company clearly has the data, so why is it being withheld? Both Afrezza inhalers cause decreased lung function in patients. MannKind says the lower FEV1 is not clinically significant, but of course, this will be a safety issue only settled by FDA and/or an advisory panel. Some 30% of the patients using the Afrezza Dreamboat inhaler reported cough as an adverse event.
$vicl MANIPULATIVE SHORTS, CORRUPT journalist drive down the market cap of VICL, then FOOLISH journalist points to mkt cap ...— ken luskin (@kenluskin1) August 11, 2013
@rhmconsultants M, If you are short Vical shares you will need more than meditation to deal with financial disaster.— ken luskin (@kenluskin1) August 11, 2013
@BasatsStockBag booger head... you are CLULESS! How many shares are you short? Should we advise suicide hot line to be prepared?— ken luskin (@kenluskin1) August 11, 2013Note the dates on Luskin's tweets. Here's what happened to Vical soon after: VICL data by YCharts
Next up, Osiris Therapeutics ( OSIR):
Am I the only one that is uber-skeptical of this $OSIR data?— Jason Napodano, CFA (@JNapodano) August 14, 2013No, Jason, you're not alone. Alexey Bersenev, who tweets under the handle @cell_nnm, collected negative (smartly so) Twitter reactions to the Grafix diabetic foot ulcer data. On his blog, Bersenev also questions Osiris' claim that Grafix is a true stem-cell product: To me, there is no any piece of evidence that Grafix indeed "stem cell product." Based on what Osiris is making a claim about it? Based on presence of MSC in the product? Well, let me tell you this - every piece of tissue mashed in a dish will contain some sort of stem cells and more likely they will be MSC or alike. Is it a valid reason to qualify product as "stem cell product"? NO! A drop of blood contains stem cells, but blood transfusion products are not "stem cell products." Donor organs for transplantation contain stem cells, but they are not "stem cell products." Reality check on Osiris: CEO Randy Mills is making some ludicrous claims about Grafix and its wound-healing ability. Grafix is not an FDA-approved drug or medical device. Grafix is a bandage embedded with unmodified and uncultured cellular tissue derived from human placentas and other growth factors. As such, Grafix is considered by FDA to be a human cells, tissue and cellular and tissue-based product, or HCT/P, which means it can be sold without regulatory review as a drug or medical device. Grafix competes against many other, similar HCT/P products in the diabetic foot ulcer/wound-healing market. MiMedx Group's ( MDXG) EpiFix is just one example. The most commercially successful wound-healing products -- Shire's ( SHHPY) DermaGraft and Organogenesis' Apligraf -- are actually classified as medical devices because they underwent formal FDA regulatory review. Osiris' diabetic foot ulcer study compared Grafix to a plain bandage so the company cannot make any comparisons of Grafix to competing wound care products. In fact, all of these products are essentially the same and have similar wound-healing properties. Osiris' Mills says Grafix is the best wound-healing product but this is just stock-promoting marketing blather. He has no data to back up his boast. In typical Osiris fashion, important details about the Grafix study, including baseline characteristics of the patients, wound recurrence and persistence of response data, have not been disclosed. The study has not been published or presented at a medical meeting yet. Osiris has a bad habit of using press releases to promulgate half-truths about clinical trial results, so there's no reason to believe last week's Grafix data announcement is any more transparent.
@PropThinker @shaneblackmon The $AMRN FDA panel run up should start soon, I imagine.— Adam Feuerstein (@adamfeuerstein) August 8, 2013The stock offering in early July, which priced at $5.60 per share, was a profitable exit point for shorts, as I mentioned in this article. I have spoken to a few Amarin shorts who cashed out soon after this deal was announced. Victory, moving on, they said. If Amarin fits the pattern of other biotech stocks, we should see a run-up into the October FDA panel. It sorta looked like Amarin was going to rally earlier this month, but the buying fizzled. Perhaps we'll see a stronger rally in September when summer vacations end. I'm still negative on the FDA panel outcome, believing experts will want to see cardiovascular outcomes data from the REDUCE-IT study before Vascepa "Anchor" is approved. -- Reported by Adam Feuerstein in Boston. Follow @AdamFeuerstein