MNTA FoB program I try not to double post, but I made the mistake of putting this on the happy board first, and no one there seems willing or able to directly address it:
>>One thing CW said concerns me, as it does not square with what I understood about the FoB pathway. My understanding was that Congress had legislated the pathway, and the FDA was in the process of figuring out the details of implementing it. Said details to be issued in the form of guidelines any day now.
CW seemed to say that it has to go back to the Hill. See this from the seekingalpha transcript:
CW: " . . . FDA pathway is just now moving around of (sic: I assume this is a typo & should read "off") the regulator FDA and in to the realm of the political on the hill. And that all has to be actually passed into Law which most likely would happen about a year from now, a year like next Octobers when we expect it would actually put into law where you actually have the pathway established."
I have been less optimistic than most here on the timing of an FoB partnership, as I did not see a partnership before the guidelines were there, and that I didn't expect them till the end of this year at earliest. Since then, we have seen them in draft form, and seen the FDA talking about officially producing them in a matter of days or weeks . . . a couple of months ago. I could buy a prospective partner looking at the draft guidelines and saying that's sufficient for them to do a deal, but not if the guidelines are going to be a political football as CW seems to be saying.
This disconnect has me discounting any excitement folks are hearing when CW talks about the FoB program, as if something substantial there is imminent.
Would love to have someone convincingly reconnect me.
Regards, RockRat<<
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