Innovation Pharmaceuticals Inc (IPIX)

[loanranger]

"Special designations, such as Fast Track, Priority Review and Orphan Drug status, are awarded by the FDA to companies with particularly promising drugs under development."

Except the premise provided isn't quite accurate. The FDA website indicates that criteria other than "particularly promising" determine whether a drug is suitable for the indicated designations.:

"Fast track is a process designed to facilitate the development, and expedite the review of drugs to treat serious conditions and fill an unmet medical need."

"A Priority Review designation will direct overall attention and resources to the evaluation of applications for drugs that, if approved, would be significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to standard applications."

"The Orphan Drug Designation program provides orphan status to drugs and biologics which are defined as those intended for the safe and effective treatment, diagnosis or prevention of rare diseases/disorders that affect fewer than 200,000 people in the U.S., or that affect more than 200,000 persons but are not expected to recover the costs of developing and marketing a treatment drug."

That said I'm sure the FDA also takes a drugs potential for approval into consideration, but I don't think "particularly promising" gets you any of those designations.