There is a probably reason behind the recent increase in SP and market interest. If you have been following Dr. Kenneth Olivier of NIH who is the director of the coordinated Phase IIb NTM study, you will see that he has been developing substantial basic medical science information about Arikace and the associated liposome. The scientific cornerstones of the NTM file are:
1. The contract biofilm penetration study of the INSM liposome (with or without amikacin) that was completed prior to the merger by Transave. Biofilm penetration places the liposome inside the biofilm and directly against mucous membrane that lines the respiratory system. It also places any antibiotic inside the biofilm, which can cover and protect any bacteria in the biofilm form being exposed to an antibiotic alone.
2. The liposome is also taken up by the fixed macrophages of the lung which is where NTM bacteria can hide and where the immune response of the lung is generated.
3. KO recently published a paper where he can perform a pulmonary scintoscan with Amikacin and image exactly where the liposome associated with any dose goes in the lung.
4. KO also developed a sputum sampling technique which is semi-quantitative for the number of NTM bacteria per mL of sputum. NTM bacteria take weeks to grow in bacteria culture and this KO method allows qualitative and semi-quantitative diagnosis of the degree of infection of a patient's lungs with NTM.
These facts have led analysts and investors who perform DD to hold through all the trivialities of the prior INSM administration. I believe that they recognize that INSM may get NTM approval as a result of the efficacy demonstrated in the Phase IIb trial.