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Posted On: 08/27/2020 1:20:08 PM
Post# of 148917
Re: dawsonmackay #52641
Frank, on the Yahoo board wrote this two hour ago:
To use Nadars words: not AF, not WSJ and not SA or any other lies will decide on the final outcome regarding approval. And also not the stockprice at that very moment. All what counts eventually will be the results of the clinical studies. And All what I have seen so far, from the mode of Action, the IND patients, the M&M Trial, the input from world class scientists including Patterson makes me very confident that the outcome will be EUA from mild to moderate to severe and also critical. I have zero doubt about this. Some of you know, others may have missed it so far, I worked for 4 years for the European Medicine Agency, another 4 years for a national European drug agency and 15 years now in another European regulatory scientific Agency.
Today I have sold another part of my gold ETF and I am going to buy more of that company. I suspect that will be a W correction which will be a very solid basis for the near and midterm future.
Like you I am annoyed by these unprofessional, misleading or even intendently misleading „journalism“, some of them blunt liars (AF). But don‘t be too annoyed about the shorts. Every shorted stock has to be covered eventually and then this will (over)compensate what you may perceive today as a „loss“.
It is not a loss, you still own the same proportion of this company.
I can understand that those with less scientific background get easier doubt than people with scientific background. I have read a lot here about leronlimab, it’s mode of action and when I worked for the Eiropean Medicine Agency I was responsible for vaccines, interleukin (I assessed with colleagues and experts the one from Amgen), and monoclonal antibodies. In addition I did. my PhD in Virology and meolecular biology. Although some of the above is already 15-25 years ago, I still understand that stuff.
In my last 15 years I was working at a higher position in risk assessment and public health and when I see I have assessed more than a 1000 clinical studies (from full pharmaceutical study reports of 300-800 pages to shorter scientific articles in peer reviewed journals.
I tell you: leronlimab will be approved. You may have seen all my considerations about the need of a phase IIi study or direct EUA.
At the end I just don‘t know when, because FDA, EMA, UK MHRA have all some margin here: they can approve, but they may also ask for a confirmatory P3 study. BOTH could be reasonably argued for M&M. Whatever outcome, I will NOT blame these drug bodies, because I know you could argue more as a scientist (then you would ask for phase III study), but the decision could also be more a risk management decision (EUA is that per se) and argue: no concern on safety plus NEWS2 data, IND results and MoA supportive evidence - approval.
Regarding S/C III - THIS will result to EUA, but again, I do not know whether p-value below 0.05 is already achieved with 195 patients (we just have them since 2 days or so) or whether we need the full 390 patients. That depends largely on the mortality rate in this study population (statistically: the more the better!) and from the effect size of leronlimab on mortality.
I am annoyed by WSJ misleading and false articles, low creature AF would do anything for money.... but who cares: We have leronlimab, this drug works and we all, owing this company will show that to the whole world. And when this happens this year (maybe tomorrow, maybe October, maybe later) we all will be very proud. Proud for our investment decisions and proud for what we have supported with our investment: saving lives of fathers, mothers, grandparents, friends, maybe even our own. Keep faith, by my daughter, this science is real and true.
To use Nadars words: not AF, not WSJ and not SA or any other lies will decide on the final outcome regarding approval. And also not the stockprice at that very moment. All what counts eventually will be the results of the clinical studies. And All what I have seen so far, from the mode of Action, the IND patients, the M&M Trial, the input from world class scientists including Patterson makes me very confident that the outcome will be EUA from mild to moderate to severe and also critical. I have zero doubt about this. Some of you know, others may have missed it so far, I worked for 4 years for the European Medicine Agency, another 4 years for a national European drug agency and 15 years now in another European regulatory scientific Agency.
Today I have sold another part of my gold ETF and I am going to buy more of that company. I suspect that will be a W correction which will be a very solid basis for the near and midterm future.
Like you I am annoyed by these unprofessional, misleading or even intendently misleading „journalism“, some of them blunt liars (AF). But don‘t be too annoyed about the shorts. Every shorted stock has to be covered eventually and then this will (over)compensate what you may perceive today as a „loss“.
It is not a loss, you still own the same proportion of this company.
I can understand that those with less scientific background get easier doubt than people with scientific background. I have read a lot here about leronlimab, it’s mode of action and when I worked for the Eiropean Medicine Agency I was responsible for vaccines, interleukin (I assessed with colleagues and experts the one from Amgen), and monoclonal antibodies. In addition I did. my PhD in Virology and meolecular biology. Although some of the above is already 15-25 years ago, I still understand that stuff.
In my last 15 years I was working at a higher position in risk assessment and public health and when I see I have assessed more than a 1000 clinical studies (from full pharmaceutical study reports of 300-800 pages to shorter scientific articles in peer reviewed journals.
I tell you: leronlimab will be approved. You may have seen all my considerations about the need of a phase IIi study or direct EUA.
At the end I just don‘t know when, because FDA, EMA, UK MHRA have all some margin here: they can approve, but they may also ask for a confirmatory P3 study. BOTH could be reasonably argued for M&M. Whatever outcome, I will NOT blame these drug bodies, because I know you could argue more as a scientist (then you would ask for phase III study), but the decision could also be more a risk management decision (EUA is that per se) and argue: no concern on safety plus NEWS2 data, IND results and MoA supportive evidence - approval.
Regarding S/C III - THIS will result to EUA, but again, I do not know whether p-value below 0.05 is already achieved with 195 patients (we just have them since 2 days or so) or whether we need the full 390 patients. That depends largely on the mortality rate in this study population (statistically: the more the better!) and from the effect size of leronlimab on mortality.
I am annoyed by WSJ misleading and false articles, low creature AF would do anything for money.... but who cares: We have leronlimab, this drug works and we all, owing this company will show that to the whole world. And when this happens this year (maybe tomorrow, maybe October, maybe later) we all will be very proud. Proud for our investment decisions and proud for what we have supported with our investment: saving lives of fathers, mothers, grandparents, friends, maybe even our own. Keep faith, by my daughter, this science is real and true.
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