Interview with an FDA Process Expert - Pre Questions, page-2

Apologies for blank post, editor went a bit crazy:

Back in September 2020 we conducted an interview with an FDA Process expert, someone that has been involved with the submission of numerous applications from a broad range of indications

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Here are the two parts for this interview conducted last year if you haven'tread them:

PART 1

PART 2


I will be sitting down with Mr X. for a follow up mini interview early next week and wanted to ask you guys if you had any questions you would like to add that are related to the FDA application process in general. Note: This guy, we will call him Mr X, has very little specific knowledge of PAR and certainly little to no knowledge of our application and our drug specifically.

Below are some typical questions that I will be asking that have been rounded up from others so far.




Paradigm submitted an IND application to FDA on 26th March 2021 for its drug(PPS) to treat Osteoarthritis. Paradigm received few questions from FDA during the 30 day review period. On 23rd April 2021 the FDA advised Paradigm that it would be putting further questions to the company within the next 30 days.Based on discussions with the FDA Paradigm believes the questions relate to newly submitted non-clinical data which formed part of the IND application.

Questions are:



1. Have you seen or heard of evidence yourself of drug applications being unusually delayed at the FDA at present due to Covid workloads?



2. We are trying to get a sense for how long the IND application might remain on hold and when the IND might open. We believe that once the FDA provide questions to the company and the company responds to such questions the 30 calendar day window restarts. Does the FDA typically try to bundle all questions to the sponsor in one round or can there be multiple rounds of questions?



3. There is some evidence that the drug to be trialled often causes a temporary benign rash at the injection site.
There has been some external suggestion that this could potentially compromise the double blinding aspect of the Phase 3 trial given that it will be known to some people (both administering and participants) as to whether they are receiving the placebo or actual drug. Surely this sort of minor AE occurs regularly in drug trials. Based on your experience what is the FDA's likely view? Would the trial design need to be tweaked to ensure blinding is not compromised?

If you guys can think of any pertinent questions, post below in this thread by Sunday 8pm 16th May. There is no guarantee your (or the above) questions will be asked/answered, subject to usual time constraints etc.




DYOR