Replies to post #110527 on Biotech Values

[DewDiligence]

FoB's are not yet ripe in my view - need to wait for the final FDA guidance before embarking on an expensive program.

I disagree with that assessment and strongly so.

Although not fully specified, the approval pathway for FoB’s is sufficiently elucidated to enable such companies as MNTA to proceed with development without incurring undue regulatory risk. Indeed, MNTA has already told investors that it intends to advance its FoB programs with expedition.

Holding off on FoB programs in order to obtain more regulatory “clarity” would be the height of folly, IMHO.

[dewophile]

FOB's are not yet ripe in my view - need to wait for the final FDA guidance before embarking on an expensive program.

sandoz has said they have 8 or so FOBs in development, and teva is already running a trial, so if mnta doesn't want to be left behind they had better get going (most accept that one trial - at least initially - will be needed even before final guidance is issued)

If this turns out to be correct (going it alone on 118) I suspect the market will not like it much.

i agree. the only scenario which might make sense is if mnta states very specifically they have partner(s) in waiting pending a successful 2b in a specific trial setting. the most bullish scenario would be to go straight to a registrational trial with a partner, and needing the cash up front to secure their share of trial cost (i may be in fantasy land here)