The way I interpret this post is they submitted the results to the FDA to request EUA for M/M and the FDA denied the EUA. How else can the FDA issue an opinion without looking at the data? There is only one way to request EUA and that is to submit data. This is the truth of the matter, but it wasn't communicated to shareholders that way.
Look, it's ok that we didn't get M/M EUA as it's only one of numerous catalysts and many thought this would be a long shot. My beef isn't with not getting M/M EUA. My problem is with how Nader failed to provide a precise roadmap for the regulatory path to the EUA while at the same time pumping the impressive results incessantly and issuing a PR indicating results were submitted for approval. I feel this was misleading after today's call where Nader said they never 'formally applied' - that's just not true. Expectations were raised and to say they under delivered would be generous.
For the record, I'm not a basher, far from it. In fact, I've invested countless hours of my life in defense of this company and leronlimab and have turned on several investors to CYDY. Today's call was disturbing to me, sorry to say. I can't turn my brain off when it's convenient to do so.
I'm still optimistic about the future path for leronlimab based on the science and am hopeful we'll get good results out of CD12.
Look, it's ok that we didn't get M/M EUA as it's only one of numerous catalysts and many thought this would be a long shot. My beef isn't with not getting M/M EUA. My problem is with how Nader failed to provide a precise roadmap for the regulatory path to the EUA while at the same time pumping the impressive results incessantly and issuing a PR indicating results were submitted for approval. I feel this was misleading after today's call where Nader said they never 'formally applied' - that's just not true. Expectations were raised and to say they under delivered would be generous.
For the record, I'm not a basher, far from it. In fact, I've invested countless hours of my life in defense of this company and leronlimab and have turned on several investors to CYDY. Today's call was disturbing to me, sorry to say. I can't turn my brain off when it's convenient to do so.
I'm still optimistic about the future path for leronlimab based on the science and am hopeful we'll get good results out of CD12.
Quote:BioInvestor4 Wednesday, 09/16/20 08:46:48 PM
Re: Amatuer17 post# 117246 0
Post #
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Actually this is not true. There is no application for EUA... It can obviously be discussed with the FDA and the FDA can grant it at their own discretion, but there is not an application.... there is an application for Diagnostics but not for drugs. The only application for a drug is for regular approval... pharma’s can however submit results to the FDA and ask them to look at it for EUA... which was done
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