All very good. And, no partnering for either CF or NTM. Modest sales force needed. 24 in US and 24 in Europe. Commercialization: CF in Europe early 2015, NTM in US early 2015. Will dialogue with FDA to see how they can use CF and NTM data for US CF filings. 35,000 CF pts in Europe. 50,000 NTM in US. Worth listening to archive of talk and questions.
Each WL presentation gives both background and "forward leaning" information:
Transave originally tried to represent the liposome as a "vehicle" to get durg into the pulmonary airway/parenchyma. FDA said, "No." This was for the obvious reason that a liposome and amikacin in a new molecule. This is the basis of a patent, BTW.
The big piece of information was the INSM had to convince the FDA that FEV-1 was a primary measure or therapy for an antibiotic containining liposome versus "time to exacerbation." Only a clinician would understand the difference, but "antibiotics kill bacteria" and are not "pulmonary function adjuncts." The point is that Arikace is both, so neither is the primary measure of efficacy. A very subtle point, but WL stated it will and that clarifies why Transave/INSM under the previous management got scientifically stalled in August 2011.
No partnering in US or Europe (possibly Japan). No R&D or marketing partners. Model for Europe is based upon realistic regulatory filings not universal approach. WL said, "We may market in Barzil before Greece."
Very straight forward.
Food fight over shares on Wednesday. Timing is everything.
The real dialogue will be the 1x1 meetings with Will...No reason to partner as solid data will allow you the most flexible opportunities and easier sale of company when/if he decides to go down that route. More leverage when you have the clinical data. Another opportunity with this pullback - pick/choose your spots...=)