Anyone who has ever worked for a biopharma can tell from the "career" section at the INSM website that INSM is "gearing-up" to market. Also the fact that they are looking for a senior director of new formulations and a contract scientist (probably a post doc) strongly suggests they are looking into new formulations with the liposome. The next couple of drug candidates through 2014 and on will tell INSM's future. WL has not made a mis-step yet. And the company will not be sold unless a big biopharma comes up with megabucks. WL has his own $billion company in the near future.
[ If the EAP for NTM proves that patients do not have to endure the 6 month "standard attempted Rx" for NTM ... ]
- you are so obviously a clown looking to boost your ego by putting up posts loaded with technical jargon that your posts are painful to read.
Make a New Year's resolution to try to grasp the concept that your inability to properly understand the issues on which you post leads us to wonder if you are just another invention of the resident multi-id delusional half-wit.
NTM is winding-down and the CF/Pa in Phase III for Europe is in the writing phase. Expenses for INSM now are directed towards cGMP validation of manufacturing sites, regulatory preparation of an EMEA submission (Chiltren/INSM) and evaluating NTM data via the NIH QA audit group. If the NTM data points to a bona fide treatment protocol, there may not even be a Phase III clinical trial. If the EAP for NTM proves that patients do not have to endure the 6 month "standard attempted Rx" for NTM and can go directly into this protocol, INSM will vault to a much more prominent position. It is already likely that Arikace will join the rotation of inhalational antibiotics that will be considered by clinical pathologists in treating CF/Pa. All the effort now is in paperwork and meetings. Anyone who has ever worked for a health care industry company knows when the data is in, the writing phase and meetings with FDA/EMEA or other begin. Still a long way off, but the end is probably in sight for INSM upper management. WL and his staff are ahead of the curve, not in a "knee jerk reflex" response situation. These people will be hired because they are needed to complete the final tasks and start new projects. The inhalational liposome was and is the key to INSM remaining an independent, stand alone company. I asked this question of WL in one of the CCs in 2011 and he responded (sic) that he was aware of the long term potential of the liposome. EOS.
1. The CF/Pa results are already in and the long process of writing the EMEA application and (possibly an NDA for the FDA) is in progress. Remember that the Cystic Fibrosis Foundation and NIH now believe that a multiple modality antibiotic approach is the best way to prevent mutation created antibiotic resistant Pseudomonas aeruginosa.
2. Completed enrollment in the NTM study was announced by WL among his comments in a
CC about two months ago.
What Longs still do not appreciate is the laborious task of writing these drug approval applications in such a way that they do not require extensive revisions. If a company is preparing their first application, the easiest way is to get a copy of an approved file through a FOIa (Freedom Of Information Act) source and paraphrase every sentence among the different sections. Many passages have to be written de novo because the processes, methods, raw materials, etc. are all different, but the general phraseology in each section is "boilerplate." At Baxter, we worked under the senior R&D VP's directive to do or say nothing that is novel in word or writing to the FDA. If you say something new, it causes a delay while the FDA reviewers get out their dictionaries or protocol manuals. If they have seen a similar sentence before in an approved master file, bingo. They read on and go to the next section. That simple.
But the two bookends on this MB that represent the fringe ideologies are consistent unto themselves. One is an idiot name caller and the other is a MM wanabe. I ignore both in posting.