The lady from Cannacord was a perfect Q/A person, BTW:
1. 20 X 25 kg batches in 2012 that went into patient use. The Phase III CF/Pa trial means that the source of drug is pinned down for future clinicals. The NDA can only be filed with a cGMP, validated production line. Scaling up to 50 kg will probably be fairly easy.
2. Alluded to carefully laid regulatory plans behind the scenes. Undoubtedly the work of Drucker, any regulatory imput from Chiltren and any phantom regulatory people they have behind the scenes.
3. The EAP for NTM is now explained. Setting aside this 6 month waiting (withdrawl) period before starting a patient on Arikace. If they can just transition to Arikace after an adverse reaction to conventional NTM treatment, it is going to save time, $$ and lives. Twenty-five patients is an attainable number when all they have to do is show up and be cleared as having no TB. BTW, the INSM presentation clearly distinguishes why TB is excluded. TB is transmissible human to human, NTM is from the environment.
4. At least as far as Arikace is concerned, it is a total INSM effort. No partnering, but there may be distribution people in Southern Europe and elsewhere. It is clear that the marketing people understand the global inpact of the drug.
5. Finally, the discussion about the lengths of negotiations over the sputum testing criteria for NTM clearly shows that INSM has do lots of homework. When you can get the FDA and NIH to agree to a totally novel endpoint that applies exclusively to your product and will be the standard test for future products, you have cornered the market.
As WL said, the Annual Meeting may have big news to announce.