Now definitively putting Mr. Shkreli deep into its "long forgotten" circular files -- Dr. Cameron Durrant, and his team of new leaders at the reorganized KaloBios just made a fairly heroic IND filing milestone happen, at FDA. This time last year, the company was struggling to emerge from a bankruptcy inflicted in large measure by Mr. Shkreli's endless hubris, and incompetence.
We still may quibble about how large the US market may be, but there is little doubt that, freed from the clutches of the sadly ineffectual psychopath Martin Shkreli -- this company has a great shot at a PRV, now -- worth perhaps $350 million, on resale.
To be sure, it was literally on the verge of winking out of existence in December of 2015 -- due to various alleged frauds perpetrated by Mr. Shkreli. [Soon he will be in an orange jumpsuit, and spending up to ten years at Camp Fed -- on eight indicted, but unrelated felony securities fraud counts. That trial begins in Brooklyn in the last week of June 2017.]
Here is the good news, from KBIOS, this morning (was tied up literally all day, on the day gig):
. . . .KaloBios, a biopharmaceutical company focused on advancing medicines for patients with neglected and rare diseases, today announced it has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for benznidazole for the treatment of Chagas disease, a neglected tropical disease.
The IND application is a critical part of the Company’s previously outlined plan to advance benznidazole for potential U.S. approval for Chagas disease.
“Our team continues to deliver on key milestones, progressing benznidazole on an accelerated timeline to an expected filing of a New Drug Application in the first quarter of 2018,” said Cameron Durrant, MD, chairman and CEO of KaloBios. “This work addresses enduring unmet need. People infected with Chagas disease carry a dramatic and significant increased risk of death. According to a recent PLOS Neglected Tropical Diseases paper, those infected have an almost 18 times higher risk of death from Chagas-related cardiac issues than those not infected.”
About Benznidazole
Benznidazole is an oral anti-parasitic medication used in the treatment of Chagas disease, caused by a protozoan parasite Trypanosoma cruzi carried and transmitted by triatomine insects (often called "kissing bugs"). According to the Centers for Disease Control and Prevention (CDC), an estimated 300,000 people in the United States are infected with Chagas disease, which, if left untreated, can lead to serious and potentially life-threatening cardiovascular, gastro-intestinal and neurological complications. Benznidazole is the current preferred treatment for Chagas disease in other parts of the world but is not currently approved by the FDA in the U.S. . . .
Now you know. So it could be cleared in about eight months. And I must admit, I've become a fan of these resurgent, and ethical business leaders -- now at the helm of KaloBios. Onward -- and goodnight, to all of good will.
नमस्ते
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