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TELESTA THERAPEUTICS INC T.TST

"Telesta Therapeutics Inc is a biopharmaceutical company. The Company is engaged in the research, development, manufacturing and commercialization of human health products and technologies."


TSX:TST - Post by User

Comment by investderpon Aug 27, 2015 5:07pm
168 Views
Post# 24057381

RE:Nice Close

RE:Nice Close
Their goal is to respond on time, 90% of the time.  

From https://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM270412.pdf.  Bolded for your pleasure.

---
Review performance goals: For NME NDA and original BLA submissions that are filed by FDA under the Program, the PDUFA review clock will begin at the conclusion of the 60 calendar day filing review period that begins on the date of FDA receipt of the original submission. The review performance goals for these applications are as follows:

a) Review and act on 90 percent of standard NME NDA and original BLA submissions within 10 months of the 60 day filing date.
 
b) Review and act on 90 percent of priority NME NDA and original BLA submissions within 6 months of the 60 day filing date. 

---
III. FIRST CYCLE REVIEW PERFORMANCE
A. Notification of Issues Identified during the Filing Review
1. Performance Goal: For original NDA/BLA applications and efficacy
supplements, FDA will report substantive review issues identified during the
initial filing review to the applicant by letter, teleconference, facsimile, secure
e-mail, or other expedient means.
2. The timeline for such communication will be within 74 calendar days from the
date of FDA receipt of the original submission.
3. If no substantive review issues were identified during the filing review, FDA
will so notify the applicant.
4. FDA's filing review represents a preliminary review of the application and is
not indicative of deficiencies that may be identified later in the review cycle.
5. FDA will notify the applicant of substantive review issues prior to the goal
date for 90% of applications.

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