Karma,
Brentie does a good job of covering the "forward looking comments" Al has made. Most longs believe Afrezza to be the best thing to ever happen in diabetes therapy and it may be a fact. That did not stop the FDA from using "clinical utility" for the first CRL and calling for in vivo bioequivalency despite the fact MannKind proved in vitro bioequivalency for a second CRL.
No, you are not as simpleton but the FDA is involved. They have as many agendas as the IRS with the director being married to a principal of a hedge fund that invests in pharmaceutical companies.
Swing