Monepantal FDA Conditional Approval

Last week I was asked a question by another Shareholder regarding the time frame from Phase II to gain FDA approval of "Pharmapantal" MPL for K9 Oncology Treatment.

Firstly MPL as an ingredient into the original Drenches and subsequently now Zolvix have already been approved into the Human Food chain 20 years ago. MPL has already been consumed by hundreds of millions of people. (Elanco are sharing that 20 years of Global Data with PAA to assist with satisfying Trial Regulations)

Pharmausts Phase II Trial has already been Approved by the Australian regulators.

There is the ability to go directly from K9 Trial directly to FDA Conditional Approval .

FDA's conditional approval allows the drug company to legally sell the animal drug before proving it meets the “substantial evidence” standard of effectiveness for full approval. ... FDA reviews the application and, if appropriate, fully approves the drug.

Also there is legislation to make Close Companion Drugs more available and swifter to market ,, in some cases where the greater good can be shown ,,fees are waived,, especially if there is no current treatment in that field/sector, this is well worth a read https://www.fda.gov/animal-veterinary/development-approval-process/minor-useminor-species

You can see from the above that a company of the likes of Elanco could swiftly apply for FDA Conditional Approval , when examining some of the new Elanco Line you can see the Company have employed this Fast Track Process to get Product out to Market and on the shelves revenuing.






So with a power house behind you and the FDA Regs in Elanco and Pharmausts favour , 120 days for approval from application made is my best estimate....