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Posted On: 09/09/2021 11:43:42 AM
Post# of 149184
Re: Evil Rabbit #103136
I hope that we get EUA in the US based on interim Brazil results very quickly but submitting the promised HIV BLA by Oct 15 based on the great response we received from the FDA on the draft dose justification report would be an excellent backup.
Based on our priority review status, if we still have it, we would get a full approval by April 15th and a full approval is much more powerful than an EUA and will be required at some time for LL so let’s get full approval for HIV - it is way past due.
IMO
Based on our priority review status, if we still have it, we would get a full approval by April 15th and a full approval is much more powerful than an EUA and will be required at some time for LL so let’s get full approval for HIV - it is way past due.
IMO
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