Good morning to all, hope you are having a good weekend and keeping safe.
Last week was a bitter-sweet one. We got good results yet the stock price went down.
Both have their intricacies imho: the price was mainly affected by three factors: the short-sighted understanding that “missing” the primary end point means LL does not work. Who would infer this? Well, technical swing traders (these normally not well informed about science/fundamentals.) reading malicious press releases and hit pieces.This brings me to the second reason: the latter group of people are investors that jump in and out of stocks and/or sectors to make a quick buck. I call them the “suicidal” investors. It is VERY difficult to make serious money this way, some are invested for few hours, some for few days. On 8/11 the announcement of the “Russian” vaccine acted as a “dog-whistle” and a huge amount of money was withdrawn and re-deployed in the market’s COVID space. If in doubt, check out what happened with AMPE, TRIB, HGEN, RLFTF and so on.
BTW, it seems that now they are restricting the target population and some scientists are coming out of the wood-work with concerns:
Russia Coronavirus vaccine: Russia's top respiratory doctor quits over 'untested COVID vaccine'; calls it gross violations of ethics
https://timesofindia.indiatimes.com/life-styl...540389.cms
There is a very large amount of money circulating in this area managed by this kind of investors, with deep pockets; you can call it a bubble if you wish, that are playing “COVID roulette” in the stock market. We did relatively well in this area as our “losses” on 8/11 were somewhat tame, they have, however spilled over the next days (similarly with related other stocks) as these opportunistic short-term investors move to their next “bet”. The third factor has been some selling probably coming from warrant holders as the outstanding share increase would indicate. It is not possible to be sure as some will sell, some other would not.
The bottom line, as far as I am concerned, is that we got very positive results. I wish CYDY would release to us the numbers, namely the other outcome measures:
1. Change in size of lesion area by chest radiograph or CT [ Time Frame: Day 14 ]
2. Change from baseline in serum cytokine and chemokine levels [ Time Frame: Days 3, 7, and 14 ]
3. Change from baseline in CCR5 receptor occupancy levels for Tregs and macrophages [ Time Frame: Days 3, 7, and 14 ]
4. Change from baseline in CD3+, CD4+ and CD8+ T cell count [ Time Frame: Days 3, 7, and 14 ]
This is the key. We are trying to probe to FDA that LL worked rapidly (3 days). If I am a FDA (honest) official and somebody tells me: I could not stablish statistical difference at day 14 because my patients and some of the placebo cohort resolved on their own BUT mine did it quicker and prevented SAEs. What do I look at??? Simple: the time-progression of CD3, CD4, and CD8 counts and corresponding ratios !!! This will tell me the tale with no doubt .
So, if after doing this FDA says, sorry, it is good but I need better statistics (more patients). Which can and has happened, we will need to just do it. And quickly.
We have been a very lucky bunch (in COVID). Most of us are here because of HIV and Oncology. I said we are lucky because by now one would expect that several therapeutics would have been approved. There have been zillions of dollars and 100’s of companies racing to alleviate the pandemic (and grow the bottom line). Yet, almost zilch, just a Faucci-sponsored “positively trending” drug and another one approved in India with 20 patients in an open-label trial.
The humongous failures of the IL-6modulators Kevzara/Sarilumab Actrema/Tocilizumab have shown everybody that this is a “tough nut to crack” and have given us a much needed breathing space. BTW, it is worth remembering that Leronlimab reduced the 14 days IL-6 levels in the Montefiore patients, with a p-value of 0.0371 to normal levels (p-value 0.3431, remember in this latter value more than 0.05 is better).
Where are we in the COVID space??? We are very close to announce either a P3 or EUA for M-M either in USA or abroad and stunning results in S-C in few weeks.
I am a relatively large investor (comparisons are odious) and purchased some more shares in the last few days, but just want to stress that I am here not because COVID. This will come and go (probably, but will not be surprised if it becomes endemic). The potential of Oncology, NASH and HIV is very large. Of Humira or Keytruda/Herceptin dimensions, if you catch my drift
So, my point: The best that we can get from our COVID entrance is the institutionalization of Leronlimab. Sure, the price will go up, and substantially, but we need to enter the "principals" stage and COVID will provide the door.
We do not have any approvals yet. If COVID can provide the first one, I will be a very happy camper.
Why?? We will be then taken seriously, never mind that COVID is probably a condition easier to address than Cancer or NASH, however, for simple-minded or, better, uninformed folk (not trying to be condescending here) we will be the "company with the COVID drug" . And we will be listened to when we talk (including FDA, media and government).
Once again, the SP will be higher, but imo COVID could be just the entrance. An approval will provide the bang.
Last week was a bitter-sweet one. We got good results yet the stock price went down.
Both have their intricacies imho: the price was mainly affected by three factors: the short-sighted understanding that “missing” the primary end point means LL does not work. Who would infer this? Well, technical swing traders (these normally not well informed about science/fundamentals.) reading malicious press releases and hit pieces.This brings me to the second reason: the latter group of people are investors that jump in and out of stocks and/or sectors to make a quick buck. I call them the “suicidal” investors. It is VERY difficult to make serious money this way, some are invested for few hours, some for few days. On 8/11 the announcement of the “Russian” vaccine acted as a “dog-whistle” and a huge amount of money was withdrawn and re-deployed in the market’s COVID space. If in doubt, check out what happened with AMPE, TRIB, HGEN, RLFTF and so on.
BTW, it seems that now they are restricting the target population and some scientists are coming out of the wood-work with concerns:
Russia Coronavirus vaccine: Russia's top respiratory doctor quits over 'untested COVID vaccine'; calls it gross violations of ethics
https://timesofindia.indiatimes.com/life-styl...540389.cms
There is a very large amount of money circulating in this area managed by this kind of investors, with deep pockets; you can call it a bubble if you wish, that are playing “COVID roulette” in the stock market. We did relatively well in this area as our “losses” on 8/11 were somewhat tame, they have, however spilled over the next days (similarly with related other stocks) as these opportunistic short-term investors move to their next “bet”. The third factor has been some selling probably coming from warrant holders as the outstanding share increase would indicate. It is not possible to be sure as some will sell, some other would not.
The bottom line, as far as I am concerned, is that we got very positive results. I wish CYDY would release to us the numbers, namely the other outcome measures:
1. Change in size of lesion area by chest radiograph or CT [ Time Frame: Day 14 ]
2. Change from baseline in serum cytokine and chemokine levels [ Time Frame: Days 3, 7, and 14 ]
3. Change from baseline in CCR5 receptor occupancy levels for Tregs and macrophages [ Time Frame: Days 3, 7, and 14 ]
4. Change from baseline in CD3+, CD4+ and CD8+ T cell count [ Time Frame: Days 3, 7, and 14 ]
This is the key. We are trying to probe to FDA that LL worked rapidly (3 days). If I am a FDA (honest) official and somebody tells me: I could not stablish statistical difference at day 14 because my patients and some of the placebo cohort resolved on their own BUT mine did it quicker and prevented SAEs. What do I look at??? Simple: the time-progression of CD3, CD4, and CD8 counts and corresponding ratios !!! This will tell me the tale with no doubt .
So, if after doing this FDA says, sorry, it is good but I need better statistics (more patients). Which can and has happened, we will need to just do it. And quickly.
We have been a very lucky bunch (in COVID). Most of us are here because of HIV and Oncology. I said we are lucky because by now one would expect that several therapeutics would have been approved. There have been zillions of dollars and 100’s of companies racing to alleviate the pandemic (and grow the bottom line). Yet, almost zilch, just a Faucci-sponsored “positively trending” drug and another one approved in India with 20 patients in an open-label trial.
The humongous failures of the IL-6modulators Kevzara/Sarilumab Actrema/Tocilizumab have shown everybody that this is a “tough nut to crack” and have given us a much needed breathing space. BTW, it is worth remembering that Leronlimab reduced the 14 days IL-6 levels in the Montefiore patients, with a p-value of 0.0371 to normal levels (p-value 0.3431, remember in this latter value more than 0.05 is better).
Where are we in the COVID space??? We are very close to announce either a P3 or EUA for M-M either in USA or abroad and stunning results in S-C in few weeks.
I am a relatively large investor (comparisons are odious) and purchased some more shares in the last few days, but just want to stress that I am here not because COVID. This will come and go (probably, but will not be surprised if it becomes endemic). The potential of Oncology, NASH and HIV is very large. Of Humira or Keytruda/Herceptin dimensions, if you catch my drift
So, my point: The best that we can get from our COVID entrance is the institutionalization of Leronlimab. Sure, the price will go up, and substantially, but we need to enter the "principals" stage and COVID will provide the door.
We do not have any approvals yet. If COVID can provide the first one, I will be a very happy camper.
Why?? We will be then taken seriously, never mind that COVID is probably a condition easier to address than Cancer or NASH, however, for simple-minded or, better, uninformed folk (not trying to be condescending here) we will be the "company with the COVID drug" . And we will be listened to when we talk (including FDA, media and government).
Once again, the SP will be higher, but imo COVID could be just the entrance. An approval will provide the bang.
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