Replies to post #74388 on Biotech Values

[DewDiligence]

HGSI / Albuferon – I don't know very much about the inner workings of the FDA, but my impression is that an "end of Phase II agreement", if there is such a thing, is little more than non-binding FDA guidance and advice.

An end-of-phase-2 meeting is a real thing, but anything said at such a meeting is indeed non-binding.

Would there even be a document signed by the FDA which states something about the 12% margin? I doubt it.

There might be a written transcript of the meeting but, even if there were, the transcript would not be signed by anybody at the FDA and it would not be binding on anybody.

If HSGI’s executives intimated that the output from an end-of-phase-2 meeting was as good as an SPA, they’re either out to lunch or they’re deliberately misleading investors. Regards, Dew