Innovation Pharmaceuticals Inc (IPIX)

[PlentyParanoid]

There are ways. All uncommon, but these come to mind.

Outright denial of phase 3.
FDA tells to applicant that additional phase 2 studies are needed before proceeding to phase 3. Admittedly very rare, FDA rather rejects the request for EOP2 meeting than wastes its time with a futile meeting, but it is possible that information revealed only in EOP2 meeting does not leave FDA any other choice.

Giving the applicant a tough task.
a. FDA advises to have a such trial size (or number of trials) that the applicant may not be financially ready to undertake the studies (CTIX/IPIX, AVEO)
b. FDA advises using trial design which may cause the applicant to conclude that successful phase 3 is not achievable (GSK).
c. FDA advises on indication restrictions that may cause the applicant to reconsider the market potential of the drug and make the market to re-evaluate the applicant's value even if the applicant decides to proceed.

In some cases the applicant may choose to ignore FDA's 'advice' and go ahead anyway, but that usually comes and haunts them on approval filing. Both AVEO and GSK did ignore FDA advice and went ahead. Only the bigger one got 'lucky'.