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Re: JokersWild12 post# 279

Saturday, 10/20/2018 3:12:40 PM

Saturday, October 20, 2018 3:12:40 PM

Post# of 852
Since it most likely will be quite a while till Zander starts trading, any and all progress for the foreseeable future will be reaped by ETNI.Just for interest I pulled the below from FDA website;
Conditional Approval
A conditionally approved animal drug has gone through FDA’s drug approval process except the drug has not yet met the effectiveness standard for full approval. FDA’s conditional approval means that when used according to the label, the drug is safe and has a “reasonable expectation of effectiveness.”

The conditional approval is valid for one year. The drug company can ask FDA to renew the conditional approval annually for up to four more years, for a total of five years of conditional approval. During the 5-year period, the drug company can legally sell the animal drug while collecting the remaining effectiveness data. This early marketing is good for two reasons: first, the drug is available sooner to be used in animals that may benefit from it; and second, the company can recoup some of the investment costs while completing the full approval.

After collecting the remaining effectiveness data, the company then submits a New Animal Drug Application to FDA for full approval. FDA reviews the application and, if appropriate, fully approves the drug.