Using the data provided, does HIVgone exhibit long-term efficacy? Explain.

Be aware of other key considerations for FDA approval of a drug/biologic
For week 6’s discussion, let’s dive a bit deeper into the drug approval process. After reviewing this week’s content, you should now be familiar with what it takes to get a drug to market and the considerations necessary when evaluating a new drug.
To begin, please look over the Phase III clinical trial data
Download Phase III clinical trial data
provided for the new drug, HIVgone. It’s safe to assume that all data collected during Phase I and Phase II shows a successful, efficacious and safe drug. After evaluating the data provided, decide if you would approve this drug or not. Be prepared to defend your position (Note: all data is fabricated for the purposes of this discussion and HIVgone is not a real drug).
Resources
1. Module 2: Week 6 content
2. Rubric for Weekly Discussions
3. HIVgone Phase III clinical trial data
Download HIVgone Phase III clinical trial data
What to Include
Complete your discussion by submitting a written post that includes answers to the following questions:
Using the data provided, does HIVgone exhibit long-term efficacy? Explain.
Does HIVgone exhibit higher, lower, or about the same efficacy as Prezista?
To assess long-term side effects, basic lab parameters were measured in various patient populations and recorded the Table. Out of the 5 lab parameter values measured, did your drug exhibit any long-term side effects? State any side-effects and the specific disease potentially associated with it.
Does your drug exhibit higher, lower, or about the same risk for long-term side effects as Prezista?
Given your answers to questions #1 and #3, what is the efficacy/side effect ratio (also commonly referred to as the “risk/benefit” ratio) for HIVgone? Given the “risk/benefit ratio”, and your answers to questions #2 and #4, do you feel that your drug candidate has a greater risk/benefit ratio than Prezista?
If you were the FDA, would you approve this drug? Why or why not?
Submit a peer response to two fellow students. Please comment on their responses. Do you agree with their answers? Why or why not? Peer responses should be submitted in written format.

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