Davanrik was developed to treat depression. However it was later found prohibited that it also affected the hunger of the person and could be practice as a do medicates for obesity patient roles. Davanrik was currently in the pre-clinical development stage when it was offered to Merck to licence it. Since research laboratory was a subaltern company could not afford to get it with the FDA citation process. LAB offered to give the rights to Merck if pay it an initial give rundown tumble on each stage and apportion the drug through the entire FDA approval stage, manufacture the drug, securities industry the drug and pay a royalty on each(prenominal) gross revenue to LAB. Clinical Approval Stages In sort 1, the drug would be administered to 20-80 healthy volunteers to test for safety. The stage would pip 2 years. If Merck opinionated to go ahead with the first leg investment, it would cost $30 jillion including an initial $5 one million million million fee to LAB for licensing the drug. Probability of success of phase 1 is 60%.
In Phase 2, a larger number (100-300) of patient volunteers argon tested to determine if the drug is effective or not. Does the recitation of drug have any side make on patients. It was estimated that there is only 10% prospect that Phase 2 would show that Davanrik would be effective for depression only, 15% chance for weight loss only, and a 5% probability for both(prenominal) depression and weight loss. This phase would also require 2 years and would cost $40 million including a $2.5 million licensing milestone payment to LAB.If you want to get a teeming essay, order it on our websi! te: OrderCustomPaper.com
If you want to get a full essay, visit our page: write my paper
No comments:
Post a Comment