Your assessment of a looming FDA approval has much gravitas..while it provides much-needed cover for their A$$...I believe we are getting a look behind the curtain on their strategy of maintaining a public image and allowing for a demonstration of the efficacy of the Molecule by providing the EIND for doctors that are PAYING attention to their patient's needs. This has allowed the FDA a failsafe mechanism in which to defend themselves against future investigational inquiries....This has not been an easy road for them or the Medical community at large......but time is crucial for many.....dependent and waiting..