Ok, before everyone jumps on the "worthless PR" ba
Post# of 30066
Posted On: 09/29/2014 4:53:46 PM
Ok, before everyone jumps on the "worthless PR" bandwagon, let's stop and think about what we can learn from today's news. The company has formally submitted a request for a pre-IND meeting to the FDA. This is a "Type B" meeting as defined in this guidance document:
www.fda.gov/downloads/Drugs/Guidances/ucm153222.pdf
Here's what it says regarding Type B meetings:
"Type B meetings should be scheduled to occur within 60 days of FDA receipt of the written meeting request."
Translation: The company will most likely be sitting face-to-face with the FDA within the next 60 days, unless the meeting is denied for a "substantive" reason (see page 5 of the document).
"Timing of Submission
A meeting package should be submitted to the appropriate review division so that it is received in accordance with the following time frames:
Type B meeting — At least 4 weeks before the formal meeting."
Translation: The company will most likely be providing detailed information on their proposed Eltoprazine trial to the FDA via a meeting package within the next ~30 days (60 day scheduling window minus 4 week submittal deadline)
And what exactly will be in the information package?
"Meeting packages generally should include the following information:
1. Product name and application number (if applicable).
2. Chemical name and structure.
3. Proposed indication.
4. Dosage form, route of administration, and dosing regimen (frequency and duration).
5. An updated list of sponsor or applicant attendees, affiliations, and titles.
6. A background section that includes the following:
a. A brief history of the development program and the events leading up to the meeting.
b. The status of product development (e.g., the target indication for use).
7. A brief statement summarizing the purpose of the meeting.
8. A proposed agenda.
9. A list of the final questions for discussion grouped by discipline and with a brief summary for each question to explain the need or context for the question.
10. Data to support discussion organized by discipline and question. For example, for an end-of-phase 2 meeting, this section should include the following, if not already provided in the background section (refer to item #6 above): description and results of controlled trials conducted to determine dose-response information; adequately detailed descriptors of planned phase 3 trials identifying major trial features such as trial population, critical exclusions, trial design (e.g., randomization, blinding, choice of control group, with explanation of the basis for any noninferiority margin if a noninferiority trial is used), choice of dose, primary and secondary trial endpoints; and major analyses (including planned interim analyses and adaptive features, and major safety concerns)."
www.fda.gov/downloads/Drugs/Guidances/ucm153222.pdf
Here's what it says regarding Type B meetings:
"Type B meetings should be scheduled to occur within 60 days of FDA receipt of the written meeting request."
Translation: The company will most likely be sitting face-to-face with the FDA within the next 60 days, unless the meeting is denied for a "substantive" reason (see page 5 of the document).
"Timing of Submission
A meeting package should be submitted to the appropriate review division so that it is received in accordance with the following time frames:
Type B meeting — At least 4 weeks before the formal meeting."
Translation: The company will most likely be providing detailed information on their proposed Eltoprazine trial to the FDA via a meeting package within the next ~30 days (60 day scheduling window minus 4 week submittal deadline)
And what exactly will be in the information package?
"Meeting packages generally should include the following information:
1. Product name and application number (if applicable).
2. Chemical name and structure.
3. Proposed indication.
4. Dosage form, route of administration, and dosing regimen (frequency and duration).
5. An updated list of sponsor or applicant attendees, affiliations, and titles.
6. A background section that includes the following:
a. A brief history of the development program and the events leading up to the meeting.
b. The status of product development (e.g., the target indication for use).
7. A brief statement summarizing the purpose of the meeting.
8. A proposed agenda.
9. A list of the final questions for discussion grouped by discipline and with a brief summary for each question to explain the need or context for the question.
10. Data to support discussion organized by discipline and question. For example, for an end-of-phase 2 meeting, this section should include the following, if not already provided in the background section (refer to item #6 above): description and results of controlled trials conducted to determine dose-response information; adequately detailed descriptors of planned phase 3 trials identifying major trial features such as trial population, critical exclusions, trial design (e.g., randomization, blinding, choice of control group, with explanation of the basis for any noninferiority margin if a noninferiority trial is used), choice of dose, primary and secondary trial endpoints; and major analyses (including planned interim analyses and adaptive features, and major safety concerns)."
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