(Total Views: 359)
Posted On: 05/03/2019 5:38:10 AM
Post# of 157207
For priority review the fda will tell them within 60 days of bla submission. Based on the criteria, I fully expect they will receive it. And with the rolling review giving the fda a head start, I suspect it could be as little as 3 months
Here is the review time of all hiv drugs until 2018
https://www.fda.gov/patients/hiv-treatment/an...-infection
~10/36 3 months
~24/36 < 6 months
https://www.fda.gov/patients/fast-track-break...ity-review
A Priority Review designation will direct overall attention and resources to the evaluation of applications for drugs that, if approved, would be significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to standard applications.
Significant improvement may be demonstrated by the following examples:
evidence of increased effectiveness in treatment, prevention, or diagnosis of condition;
elimination or substantial reduction of a treatment-limiting drug reaction;
documented enhancement of patient compliance that is expected to lead to an improvement in serious outcomes; or
evidence of safety and effectiveness in a new subpopulation.
FDA decides on the review designation for every application. However, an applicant may expressly request priority review as described in the Guidance for Industry Expedited Programs for Serious Conditions – Drugs and Biologics. It does not affect the length of the clinical trial period. FDA informs the applicant of a Priority Review designation within 60 days of the receipt of the original BLA, NDA, or efficacy supplement. Designation of a drug as “Priority” does not alter the scientific/medical standard for approval or the quality of evidence necessary.
Here is the review time of all hiv drugs until 2018
https://www.fda.gov/patients/hiv-treatment/an...-infection
~10/36 3 months
~24/36 < 6 months
https://www.fda.gov/patients/fast-track-break...ity-review
A Priority Review designation will direct overall attention and resources to the evaluation of applications for drugs that, if approved, would be significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to standard applications.
Significant improvement may be demonstrated by the following examples:
evidence of increased effectiveness in treatment, prevention, or diagnosis of condition;
elimination or substantial reduction of a treatment-limiting drug reaction;
documented enhancement of patient compliance that is expected to lead to an improvement in serious outcomes; or
evidence of safety and effectiveness in a new subpopulation.
FDA decides on the review designation for every application. However, an applicant may expressly request priority review as described in the Guidance for Industry Expedited Programs for Serious Conditions – Drugs and Biologics. It does not affect the length of the clinical trial period. FDA informs the applicant of a Priority Review designation within 60 days of the receipt of the original BLA, NDA, or efficacy supplement. Designation of a drug as “Priority” does not alter the scientific/medical standard for approval or the quality of evidence necessary.
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