Innovation Pharmaceuticals Inc (IPIX)

[seek the light]

Empiricst1.....I think i found the starting point if you are really interested in doing research on the FDA approvals for 2017:

https://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ReportsBudgets/UCM591976.pdf


Here is an excerpt that might interest all IPIX shareholder:

"Innovation: Frequent Use of Expedited Development and Review Pathways
CDER used several regulatory pathways to expedite the development and approval of novel drugs in 2017. These
pathways utilize a range of approaches that can enhance development efficiency and shorten timelines; these
approaches can include more interactions between CDER staff and drug developers, greater program design flexibility,
and shortened timelines for review of applications.

Fast Track
Fast Track designated drugs have the potential to address unmet medical needs. Eighteen of the 46 2017 novel drugs
(39%) were designated by CDER as Fast Track. Fast Track speeds new drug development and review, for instance, by
increasing the level of communication between FDA and drug developers, and by enabling CDER to review portions of
a drug application ahead of the submission of the complete application.
Drugs designated with Fast Track status were: Aliqopa, Bavencio, Baxdela, Bevyxxa, Emflaza, Idhifa, Ingrezza,
Mavyret, Mepsevii, Ocrevus, Prevymis, Rydapt, Solosec, Vabomere, Verzenio, Vosevi, Xermelo, and Zejula.

Breakthrough Therapy
Breakthrough therapies are drugs with preliminary clinical evidence demonstrating that the drug may result in
substantial improvement on at least one clinically significant endpoint (e.g., study result) over other available
therapies for serious or life-threatening diseases for which there is unmet medical need. CDER designated 17 of the
2017 novel drugs (37%) as breakthrough therapies. A breakthrough therapy designation includes all the Fast Track
program features, as well as more intensive FDA guidance on an efficient drug development program. Breakthrough
therapy designation is designed to help shorten the development time of a potential new therapy.

Drugs designated with Breakthrough therapy status were: Alunbrig, Bavencio, Besponsa, Brineura,
Calquence, Dupixent, Hemlibra, Imfinzi, Ingrezza, Kisqali, Mavyret, Ocrevus, Prevymis, Rydapt, Verzenio, Vosevi, and
Zejula.

Priority Review
A drug receives a Priority Review if CDER determines that the drug could potentially provide a significant advance in
medical care. The drug is reviewed within six months instead of the standard 10 months. Twenty-eight of the 46 novel
drugs approved in 2017 (61%) were designated Priority Review. Note, in some instances, priority review is assigned
as a result of the sponsor redeeming a voucher for priority review under CDER’s Priority Review Voucher program,
which may mean the drug does not potentially provide a significant advance. Such drugs are not included in the list below.

Drugs designated Priority Review were: Aliqopa, Alunbrig, Bavencio, Baxdela*, benznidazole, Besponsa,
Bevyxxa, Brineura, Calquence, Dupixent, Emflaza, Giapreza, Hemlibra, Idhifa, Imfinzi, Ingrezza, Kisqali, Mavyret,
Mepsevii, Ocrevus, Prevymis, Rydapt, Solosec*, Vabomere*, Verzenio, Vosevi, Xermelo, and Zejula. "