Buying an index fund would be equal weight for all stocks in the fund, roughly the same percentage ownership of each company. Overweight would be holding a higher percentage ownership in a given stock relative to the "field".
If a purchase is made as part of a Rule 10b5-1 plan (automatically on a schedule), then it may occur when the insider is aware of nonpublic information that would otherwise make trading illegal.
Osiris issued a press release yesterday, the same day that Feuerstein published an article about their dealings with the FDA. Called his "The Street" article a 'false and misleading' story.
I presume he is expecting something from the North American Cystic Fibrosis conference poster sessions. I would hope that Insmed makes the poster slides available on their website tomorrow.
The Tea Party are reactionary fiscal conservatives. If you are anti-Tea Party, that makes you liberal. So, you're a liberal Independent?
You must be a liberal Democrat to blame this solely on the Tea Party. The election of Tea Party candidates was mainly a reaction to the Dems passing ObamaCare without consulting with the Republicans. Then after the 2010 elections, where the Dems lost the house, the Senate Dems refused to pass a budget or negotiate in good faith. So we ended up with Continuing Resolutions instead of Appropriations and the Sequester because of budget/spending negotiation failures. Now we have a government partial shutdown because the Pres and Senate Dems again refused to negotiate on budget and spending.
When did you sell @ 14.09? I remember that on Oct 3, you said you covered your short at an 8% loss and are out of INSM.
Will Lewis was responding to a question about whether the label would be for the refractory NTM patient population (3000 to 5000 patients/year) or a broader "all NTM" label. He said the KOLs would accept any label because have a lot of off-label uses for Arikace.
CF is a genetic disorder that is predominantly found in Caucasians. It is not a "global" disease like NTM. The largest market will be Europe, followed by U.S. (large number of immigrants from Europe).
The superbugs in the "urgent" category are:
1. CRE (carbapenem-resistant Enterobacteriaceae)
2. C. difficile
3. Antibiotic-resistant gonorrhea
drug-resistant tuberculosis was mentioned as "certainly worthy of immediate response"
Are there any posts from M. abscessus patients? That one is a much nastier bug than MAC. From the quote below, about 25% of the trial patients have M. abscessus infections, 75% have MAC.
From the 2013 Q2 conference call (Seeking Alpha transcript):
Sounds good. And so, also, what kind of breakdown do you expect between MAC and M. abscessus-afflicted patients? And is this something that you're stratifying and balancing the proportions of between drug and placebo?
William H. Lewis - Chief Executive Officer, President and Director
Right. So again, a great question. I think we do stratify for the difference between MAC and M. abscessus in patients coming to the study, as well, I'll just note, for CF and non-CF patients. The breakdown between them is not inconsistent with what you see more broadly. I think perhaps a little bit more abscessus only by virtue of the fact that these patients that are coming in are severe refractory patients. So these are folks that have been on ATS-IDSA Guidelines and still with this multi-drug regimen for at least 6 months prior to screening, are showing persistently positive mycobacterial culture. So with that as a backdrop, they come in. I think, we've quoted in the past that we are giving about 1/4 of the patients or so with abscessus, and the balance with MAC. And of course, all of these patients come with co-morbidities that include things like CF, but also include non-CF bronchiectasis, COPD, et cetera.
In the investor presentation slides, there is a timeline. Estimated approval date and launch for NTM in the U.S. is 1H2015, with no P3 for NTM shown. Will Lewis has said that he expects approval based on the present P2 trial results. That suggests that he knows that Arikace is making a difference.
For those non-bacteriologists who need translation:
"CFU" - colony-forming unit is an estimate of viable bacterial or fungal numbers. Unlike direct microscopic counts where all cells, dead and living, are counted, CFU estimates viable cells. The appearance of a visible colony requires significant growth of the initial cells plated - at the time of counting the colonies it is not possible to determine if the colony arose from one cell or 1,000 cells. (Wikipedia)
"down two logs" means that the number of CFUs has been reduced by 2 decimal orders of magnitude, to 1% of the original count.
Insmed Incorporated (INSM) recently announced about two important patent allowances in the U.S. and Europe for its lead candidate, Arikace.
The U.S. Patent and Trademark Office (:USPTO) is looking to grant Arikace U.S. Patent Application No. 13/666,420 (titled lipid-based compositions of anti-infectives for treating pulmonary infections and methods of use thereof), which will expire on Dec 5, 2026.
The European Patent Office is looking to grant EU Patent Application No. 03816990 (titled sustained release of anti-infectives) for Arikace, which will expire on Oct 29, 2023. The patent will be valid in any European Patent Office member state where the company chooses to validate the patent.
Both patents will cover an aerosol composition for the treatment of pulmonary infections, including pseudomonas aeruginosa and mycobacterial infections, along with other indications, based on Insmed’s novel, once-daily inhalation formulation comprising amikacin and liposomal delivery technology.
These new patents will further boost the existing global patent portfolio of Arikace.
We note that in Apr 2013, the U.S. Food and Drug Administration granted orphan drug status to Arikace for the treatment of infections caused by non-tuberculous mycobacteria (:NTM).
"Insmed is currently conducting a phase II study on Arikace in the U.S. and Canada in patients suffering from NTM lung infection. Insmed expects to report top-line results from the study by the end of the first quarter of 2014. The company also plans to initiate a limited compassionate use program on the candidate in the second half of 2013.
If cleared by the regulatory bodies, Arikace would be the first approved inhaled antibiotic treatment for NTM lung infections.
Furthermore, Arikace is under phase III development for the treatment of pseudomonas aeruginosa (Pa) lung infections in patients suffering from cystic fibrosis (CF).
In Jul 2013, Insmed reported encouraging results from a phase III study on Arikace for the treatment of Pa in CF patients, when compared to Novartis’ (NVS) TOBI (tobramycin inhalation solution).
Insmed expects additional results from the study in the second half of this year. Arikace enjoys orphan drug status for this indication both in the U.S. and the EU. The company is currently enrolling patients for a two-year open-label extension study on Arikace for the same indication. The extension study is expected to be completed by mid 2015."