In my experience FDA can and does share draft guidance with some or all and let them start to live by that guidance before it becomes official. It is kind of like a beta test.
If the guidance is changing, they may have communicated the new guidance to NWBO and allowed them to begin the process and by sharing the guidance has all but assured them of the success of their new approach. In fact, they have been known to tell you their true target approval date which is not a guarantee but is a very real goal and much earlier than the PDUFA date. Companies need to prepare for an approval and they need cash to do it. You have materials to print, websites to build, phone lines to activate, and supplies to purchase. They understand this and work with you, not against you. If it is coming down to PDUFA and you don’t know what they will do, that is not a good sign at all. Not necessarily the death nail, but not a bed of roses either.
Oh yea, you also have contracts to execute and manufacturing suites to secure and staff to hire…
I don’t know, maybe you need an extra 15 million to get’er done and be ready.
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