MNKD今天为什么不涨反跌？

烦请老博及其他生物药学专家鉴定：

Sharon Di Stefano



Sharon di Stefano has spent 20 years as an analyst, beginning her career at Smith Barney, Harris Upham & Co. specializing in medical devices, pharmaceuticals, healthcare information technology, and biopharmacology. Ms. di Stefano had also served as Senior Venture Officer for the Edison Innovation Fund, implemented through the New Jersey Economic Development Authority that provided funding for early-stage life sciences companies. Industry experience includes laboratory research for Johns Hopkins Hospital and the Department of Defense.

今天Sharon Di Stefano 写了篇文章大肆吹捧ORMP的口服胰岛素的研发。对MNKD的AFREZZA的前景进行打压。
烦请老博及其他生物药学专家鉴定： Sharon Di Stefano 文中的论点是否成立？ 谢谢！

“All diabetics living long enough will eventually need insulin and Type 2s often delay using it, putting their health at greater risk. Oral insulin is clinically desirable because absorption through the difficult pathways of the digestive tract would go directly to the liver as opposed to making the rounds systemically where high amounts of insulin in circulation can increase risks to other organs as is so evident by the number of co-morbidities associated with diabetes. Patient compliance would be almost guaranteed. Thus, an insulin pill lends the opportunity to save billions in unnecessary medical costs.

Pharmaceutical partners are attracted to a winning technology, but there are some entrants in the race for a pioneering diabetes treatment that may not fare well. Mannkind Corp. (MNKD) could have trouble attracting partnerships because of the taint still surrounding Pfizer Inc.'s (PFE) catastrophe with its inhaled insulin product Exubera. Fans of Mannkind excitedly point to the eternally-resubmitted New Drug Application (NDA) last month for AFREZZA, its version of inhaled insulin that's becoming like a badly shopped-around financing deal. The company will clearly need a partner to market the product and memories run very short when it comes to large pharmaceutical companies committing money to a venture that badly burnt one of their brethren.

Most egregious of Mannkind's sins to investors was its recent third quarter conference call, a compilation of smoke and mirrors surrounding AFREZZA. There was discussion of market research directed to a "large sample" of endocrinologists and primary care physicians about the product with 86% saying they were "very likely" to use AFREZZA. From my own experience, any doctor focus group paid upwards of $400 for two hours of their time is bound to have a positive bent.

Next in line of absurdity was the statement that the NDA package sent to the FDA was 800,000 pages long. These are government workers, of which I once was one. If I were on a panel of advisors required to review a document that amounted to a reading of Tolstoy's War and Peace 555 times, I might miss a point or two and chances of approval could sink markedly. Lastly, Mannkind crowed about a "quality of life" survey taken among AFREZZA patients that reported, not surprisingly, a big improvement in their "self-reported health status" versus the control insulin group. Diabetic patients, like any with a chronic disease, are more than happy for the attention and opinions do not necessarily reflect value of the therapy. This is called the placebo effect and the same phenomenon that Biocon experienced that caused a restart of clinical trials.

Risks abound in any new diabetic therapy and oral insulin has specific potential pitfalls. A pill may not replace injections and may be used only in patients who still produce insulin, limiting clinical acceptance. However, it would still have clinical value in that diabetics could be encouraged into earlier treatment and reduce downstream complications like blindness, heart disease, neuropathy and kidney failure.

If early studies prove true, Oramed may have a more viable compound than Novo Nordisk for Type 1s, making it an attractive take-over candidate..."


全文链接：http://seekingalpha.com/article/1828722-oramedss-success-in-type-1-diabetes-could-solve-novo-nordisks-problems?source=yahoo