Very hard to say how things would shake out competitively if the FDA granted ABT’s request. The most likely outcome, IMO, would be an adverse effect on FoB players (including MNTA/BAX) who intend to rely on the 351(k) pathway and a marginal positive effect on such companies as MRK who intend to rely on the conventional BLA pathway (#msg-75071696).
As previously opined, I don’t give ABT’s CP much of a chance of influencing FDA policy on FoB’s.