well, I am not sure if it was you or someone else also said similar thing in the past, but there has been approvals going on in 2020, 2021 and 2022 (new or renewal or extension etc.) so point was that FDA isn't closed for business so COVID can't be used as an excuse for delay in getting approval for HDE in my opinion all these 2.5 years ... sure it may be in 2020 but now we are in 2022 ....... America never had lockdown what we saw in Australia or China or New Zealand .... In my opinion.
it is the lack of details & extension of time over last 2.5 year .... that worries me more then anything... !
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