The meeting with the FDA to discuss pathway(s) for drug approval has been set. WL is not giving the date because it might change, but we are talking about within the next month or so (mid year). Shortly after this FDA meeting, WL will issue a press release coupled with a conference call.
WL hopes for FDA approval to file Arikayce for refractory NTM without the need for any further study. In any event, WL anticipates an expedited path toward eventual new drug approval.
Insmed is gearing up for the next NTM clinical trial which will address a much broader population of NTM patients than just refractory (drug resistant) patients. WL thinks approval and commercialization of Arikayce for this broad population could be achieved by the end of 2016.
Treatment costs are pegged by WL at between $50,000 and $100,000 for a six-month therapy.
NTM prevalence is growing at the rate of 8% to 10% per year, so there will be a steady stream of new patients needing treatment for the foreseeable future.
Insmed has no known commercial competition in the NTM space.
Also his fair estimation of a $50K to $100K price tag (for 36 weeks of treatment). Insmed wants to price this fair. He admitted Insmed will like partner with "someone" for the Asia market (his team was working on that). He emphasized that this "drug" or future drugs are for other indications (mentioned some) beyond NTM and CF. when they have something viable, it will be announced. As AL said about the FDA and EMA they have solid dates scheduled but did not want to announce these should they change (market gets all frothy about reading into this).
Oh, yea, ' First company EVER to receive orphan (both US and Europe), QIDP, priority review, fast track and now breakthrough designation." as one of our posters here pointed out well. So the FDA has been moving this forward...Will said FDA "is a good partner". Good relationship, helping it move along, I think we file and run a phase 4 study which is the plan either way. al