My belief is that the company has all of the data it needs from the US RBL's or they wouldn't have submitted a Pre-Ind.
Let's hope the FDA approves the company moving forward.
Message in reply to:
Will IPIX have to wait for the pre-print to be published before it makes the IND application...you know to improve the chances of its approval, or could we go ahead with the information we have?
My concern is the IND application being declined or delayed by the FDA for want of RBL's testing results.
I would appreciate if you could shed some light on this.
No my understanding of the pre IND meeting is all the data must be complete for the application to be presented. Then the FDA will review the application and data. The applicant then has an opportunity to answer any questions.
IMO the extra studies done by the RBL the last few weeks would not have been directly related to the IND application. For example the GI and fibroblast studies.
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