I agree with you that the FDA is helping us. I do
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Posted On: 07/15/2020 11:45:59 AM
Re: generactor #43088
I agree with you that the FDA is helping us. I don't buy into the conspiracy theories that they are slowing us down.
At the end of the day, unless Leronlimab falls flat on COVID, HIV is taking a back seat anyway. Even if we had received the PDUFA date and been approved by December, we likely would be pausing the use of Leronlimab if we are approved for COVID as demand could very well exceed supply.
I am praying that our M2M results are strong enough to get an EUA, and that our severe trial is going well enough to cut it short. As a country, as a planet we NEED this.
At the end of the day, unless Leronlimab falls flat on COVID, HIV is taking a back seat anyway. Even if we had received the PDUFA date and been approved by December, we likely would be pausing the use of Leronlimab if we are approved for COVID as demand could very well exceed supply.
I am praying that our M2M results are strong enough to get an EUA, and that our severe trial is going well enough to cut it short. As a country, as a planet we NEED this.
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