Good day to all !!
Have been a bit philosophical these last few days, of the kind that comes with wounds and one licking them and watching the account with "missing zeroes"
.
This is not the first rodeo for most of us, so I will spare the comments about Biotech risks. Is always the results of trials what matters.
However, a good autopsy is always good. I am sharing below mine.
Why did I get it wrong ? Well, we had information from several sources, anecdotal or not, several companies had trial before us (I kept a record) and most of them had deaths around 30% for S/C. Ours had a lower value. Also, we had a whooping 83.85% of the patients in Severe and the overall recovery rate of this group was 18.9%. With only 16.15% in critical and overall mortality of 30.6% it was very, very difficult to establish a difference when the patients were thrown the kitchen sink concurrently with Leronlimab.
If we add the age skew we got this will affect even more the performance, however, this does not explain entirely the "grey" results.
Leronlimab helps in COVID as almost all the measurements indicate (some with statistical significance) but we did not hit a home-run.
Neither did many other drugs and, yet, they got EUA. Some were given this even showing a "positive trend".
Why not us ??? We are a small company and our trial had few patients in the "category" were we are most beneficial.
As a consequence we need to re-align.
The reality is that we are in a corner and the BOD even more. We need to go and pick the lower hanging fruit(s) and quick !!!
I said this before and will repeat it: we should run the CD-16 trial as a "side show" and concentrate in the LH trial which has a much grater potential (is huge ). However, the ultimate treatment for LH in my opinion will consist on a combination of drugs and management should be concentrating on making strategic alliances right now. The trial should be done with a combination of two or three drugs addressing different symptoms at different stages.
We have a weakness (apart from being cash-strapped), in that we do not have a strong clinical R&D department. Trying to go out there and compete with companies with tens of scientists measuring and evaluating in real time is going to be a very challenging act.
Unless of course, one has a miracle drug. But CD-12 told us LL works but is not.
We can do "exploratory" trials and find our way little by little but at the end this will not suffice (it will probably be late). We need to do trials with another drug(s) that help as well and present to the world the treatment for L.H.
I hope somebody is looking who to partner with. Hopefully a large company (BP) that will bring credibility to us. We had the best allied and inexplicably let it go. Imo this has ben the worst misstep of the BOD.
We do not have much time, the other low hanging fruit is Oncology. A BTD will mean lots for us and we should have data worth now several months (year). This fruit is low because we need to demonstrate an improvement on OS and will be able to launch a trial soon (with results measurable at a relatively short time). I believe we should have enough data by now.
So, if there is a silver lining of the CD-12 results is that management is compelled now to advance rapidly, if something, the finances should "focus" them into producing tangible results in a short time-frame.
I am very long and believe LL/VX has a very bright future. The only thing that can stop us is bad implementation.
Have been a bit philosophical these last few days, of the kind that comes with wounds and one licking them and watching the account with "missing zeroes"
. This is not the first rodeo for most of us, so I will spare the comments about Biotech risks. Is always the results of trials what matters.
However, a good autopsy is always good. I am sharing below mine.
Why did I get it wrong ? Well, we had information from several sources, anecdotal or not, several companies had trial before us (I kept a record) and most of them had deaths around 30% for S/C. Ours had a lower value. Also, we had a whooping 83.85% of the patients in Severe and the overall recovery rate of this group was 18.9%. With only 16.15% in critical and overall mortality of 30.6% it was very, very difficult to establish a difference when the patients were thrown the kitchen sink concurrently with Leronlimab.
If we add the age skew we got this will affect even more the performance, however, this does not explain entirely the "grey" results.
Leronlimab helps in COVID as almost all the measurements indicate (some with statistical significance) but we did not hit a home-run.
Neither did many other drugs and, yet, they got EUA. Some were given this even showing a "positive trend".
Why not us ??? We are a small company and our trial had few patients in the "category" were we are most beneficial.
As a consequence we need to re-align.
The reality is that we are in a corner and the BOD even more. We need to go and pick the lower hanging fruit(s) and quick !!!
I said this before and will repeat it: we should run the CD-16 trial as a "side show" and concentrate in the LH trial which has a much grater potential (is huge ). However, the ultimate treatment for LH in my opinion will consist on a combination of drugs and management should be concentrating on making strategic alliances right now. The trial should be done with a combination of two or three drugs addressing different symptoms at different stages.
We have a weakness (apart from being cash-strapped), in that we do not have a strong clinical R&D department. Trying to go out there and compete with companies with tens of scientists measuring and evaluating in real time is going to be a very challenging act.
Unless of course, one has a miracle drug. But CD-12 told us LL works but is not.
We can do "exploratory" trials and find our way little by little but at the end this will not suffice (it will probably be late). We need to do trials with another drug(s) that help as well and present to the world the treatment for L.H.
I hope somebody is looking who to partner with. Hopefully a large company (BP) that will bring credibility to us. We had the best allied and inexplicably let it go. Imo this has ben the worst misstep of the BOD.
We do not have much time, the other low hanging fruit is Oncology. A BTD will mean lots for us and we should have data worth now several months (year). This fruit is low because we need to demonstrate an improvement on OS and will be able to launch a trial soon (with results measurable at a relatively short time). I believe we should have enough data by now.
So, if there is a silver lining of the CD-12 results is that management is compelled now to advance rapidly, if something, the finances should "focus" them into producing tangible results in a short time-frame.
I am very long and believe LL/VX has a very bright future. The only thing that can stop us is bad implementation.
18
