"5. Receiving ATS/IDSA guidelines-based treatment regimen defined as: adherent to a multi-drug regimen for at least 6 months prior to screening with persistently positive mycobacterial cultures." Emphasis on the phrases, "PRIOR to screening" and "persistently positive mycobacterial cultures." This means that the enrollee was treated by the best medicine standard prior to screening for and enrollment and still had NTM infection..
"9. History of acute pulmonary exacerbation requiring treatment with antibiotics within 4 weeks prior to screening or anytime during screening." Any use of antibiotics leading up to enrollment in the Arikace study disqualifies a potential enrollee. because the physicians performing the study would never be able to discern which antibiotic worked with Arikace and which did not. This would only confound the other substantial variable which is: "The number of identified and cataloged NTM species has been increasing rapidly, from about 50 in 1997 to over 125 by January 2007. The surge is mainly due to improved isolation and identification technique." Ergo which strain of NTM was being treated.
Again, why would simultaneous treatment with any antibiotic be a conundrum? Simply because it would not isolate the effect of Arikace on the NTM versus the additive or synergistic effects of other antibiotics.
Thank you for your clarification, Rehd. Could you also please clarify your "Hold" sentiment? I understand you sold your shares. I also understand your continued interest in Insmed. However, if you don't own any shares, how do you justify your "Hold" sentiment?
- Nontuberculous mycobacteria (NTM) are germs common to water and soil that do not usually affect healthy people. People with cystic fibrosis and other lung problems, however, have difficulty clearing mucus from their lungs. Because of this mucus buildup, these people are more likely to develop NTM lung infections. Chronic or long-term NTM infections may lead to more lung function problems. However, most of the drugs used to treat NTM infections are not well tolerated and not always effective."
The facts point to INSM having a good therapeutic preparation, but one that was not as good as everyone thought. Still the option of using the inhalational antibiotic once per day speaks encourages the future clinical use of Arikace and other drugs in the liposome.
These were all direct quotations from Dr. Kenneth Olivier's NIH protocol over on NIH DOT gov, BTW.
If there was an easy answer to the question, Dr. Gupta would have gotten more shares instead of what happened. She is still associated because she is the title holder of the patent for inhalational aminoglycosides in the INSM proprietary liposome. Look it up. If they dropped her like a hot rock, there could have been a lawsuit because the liposome is and was so valuable.
Dr. Gupta was an employee of Transave at the time of filing; therefore the patent belongs to her then employer, Transave (now insmed); the fact that her name is on it means jack sh1 t. As a patent holder myself I know - means nothing if you are an employee under employee contract.