relacher, the FDA has to inspect the plant and approve it before it can be used. The plant does not have to be built before approval but building it after approval will set you back around 3 years - 1 year to build (is it easy to find the right property when you need it?), 1 year to hire personnel, test production. etc. and 6 months to1 year for FDA inspection. In addition, all the patents unique to the production cannot be discovered and filed. Meanwhile you lose 3 years of your patent life for those patents you can get without the production process. If you are unlucky some smart jackass will patent some key production process before you and you will be set back by many years. If you believe Afrezza is a $1B in sales product, that would mean you lost $3B in sales.
Al was sure that they would EVENTUALLY get approval. This is BIG stuff and you expect setbacks but you have to remain dedicated and stay on track because the benefits to humanity are so, so, big. That focus and tenacity (in addition to sheer brilliance) is a huge part of why Al has been so successful. Five year from now, no one who has stayed for the long haul will care that we got 2 CRLs.
Sentiment: Strong Buy