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Ann: IHL-675A Pre-IND meeting with FDA update, page-26

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KingHoves

125 Posts.

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25/03/21

11:48

Post #: 52031107
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Originally posted by ma420: ↑

Here is a question to those knowledgeable on the FDA’s Pre-IND process:

The FDA process guidance states that it agrees to a pre-IND meeting based on certain conditions and if grated the meeting requestor should provide meeting materials for the meeting per this guidance:
https://www.fda.gov/drugs/cder-small-business-industry-assistance-sbia/small-business-and-industry-assistance-frequently-asked-questions-pre-investigational-new-drug-ind

Per today’s Ann, FDA aims to respond to IHL by 21st of April.

Is a meeting recalling happening or will FDA will review the information package and provide IHL a response by 21st of April? Or will a face-to-face (or video) meeting take place on or before 21st? I am unclear on that part. Appreciate some clarification.

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Hi Ma

This article doesn't confirm anything either way, but contains some quite useful information:
https://www.pharmaceuticalonline.com/doc/is-an-fda-pre-ind-meeting-worth-it-how-to-decide-how-to-prepare-0001

I guess the reason the market hasn't reacted as positively as I initially expected is:

IHL Price at posting: 20.5¢ Sentiment: Buy Disclosure: Held
7 Upvote

0 Great analysis

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