I have to say that I am not looking forward to the White House’s announcement of a "major therapeutic breakthrough" on coronavirus.
I really don’t want to go into politics. We all have different points of view and this board is about investment on CYDY. But, as this announcement is probably going to be made by POTUS is political in nature.
Why I don’t like it ??? Well, the RNC convention starts today. The polls are currently negative for POTUS, all this re-enforced by the disastrous management of the COVID crisis in the USA.
All eyes are tuned to the convention and the best pre-strike is a BIG announcement on COVID and this is precisely what will be happening.
Timing says it all.
The question is: is this science based ?? Is the truth ?? Or, if you wish: is the truth ready to be told?? Or, for us: have clinical trials been concluded for this particular “breakthrough” and it is scientifically sound ???
It depends. However, referring to COVID this gives you pause, these are twits from POTUS:
And:
Would suggest that FDA will be somewhat bypassed by the announcement.
I am not a friend of FDA (for reasons completely different not related to the state but BP), but one cannot just throw the baby with the bath water.
So, which drug will be announced??. Well, one would normally go directly and check which ones have statistical data, or are about to have statistical data in double-blinded trials run by the FDA (as we are talking USA here), some obvious candidates:
Leronlimab (CYDY) . Data from P2 for M2M and ongoing P3 for S2C
Lenzilumab (HGEN). Expecting P3
REGN-EB3 (REGN) In ”adaptive trials” several phases.
However, in this highly and politically charged environment I think the announcement will not be for any drug in which the government cannot claim to have invested amounts of money and used Warp speed and basically “saved the world”.
We did not receive a penny. The White House cannot claim they did anything to get Leronlimab to succeed. Is not a “convenient” therapeutics and is not what the political environment demands. It demands something that can be claimed as a triumph, as good management, as warp speed working, as COVID will be thing of the past yesterday.
This is not us and this is why I don’t like this announcement. A drug that probably is not ready, has not been probably fully tested (as FDA is now “deep state”) will be announced now because is convenient.
To the momentary detriment of the rest of us small companies playing by the rules who will have to wait until the science really confirms or not the drug that will get the “political” spotlight, as opposed to scientific idem.
I think REGN checks all the boxes. Received $450 Million from government, made a deal with Roche for production and the production has been already purchased. They got “adaptive” trials that can be manipulated and terminated before /full enrollment deadlines. And somebody wants them terminated before Nov 3.
Another possibility is to crown Remdesivir in spite of FDA and weak scientific evidence.
I surely hope I am wrong, and don’t want to make this a political post. Just trying to share my thoughts on why we should not feel optimistic about this announcement.
I really don’t want to go into politics. We all have different points of view and this board is about investment on CYDY. But, as this announcement is probably going to be made by POTUS is political in nature.
Why I don’t like it ??? Well, the RNC convention starts today. The polls are currently negative for POTUS, all this re-enforced by the disastrous management of the COVID crisis in the USA.
All eyes are tuned to the convention and the best pre-strike is a BIG announcement on COVID and this is precisely what will be happening.
Timing says it all.
The question is: is this science based ?? Is the truth ?? Or, if you wish: is the truth ready to be told?? Or, for us: have clinical trials been concluded for this particular “breakthrough” and it is scientifically sound ???
It depends. However, referring to COVID this gives you pause, these are twits from POTUS:
Quote:Obviously, they are hoping to delay the answer until after November 3rd,” Trump tweeted, referring to Election Day. “Must focus on speed, and saving lives!
And:
Quote:The deep state, or whoever, over at the FDA is making it very difficult for drug companies to get people in order to test the vaccines and therapeutics. Obviously, they are hoping to delay the answer until after November 3rd. Must focus on speed, and saving lives!
Would suggest that FDA will be somewhat bypassed by the announcement.
I am not a friend of FDA (for reasons completely different not related to the state but BP), but one cannot just throw the baby with the bath water.
So, which drug will be announced??. Well, one would normally go directly and check which ones have statistical data, or are about to have statistical data in double-blinded trials run by the FDA (as we are talking USA here), some obvious candidates:
Leronlimab (CYDY) . Data from P2 for M2M and ongoing P3 for S2C
Lenzilumab (HGEN). Expecting P3
REGN-EB3 (REGN) In ”adaptive trials” several phases.
However, in this highly and politically charged environment I think the announcement will not be for any drug in which the government cannot claim to have invested amounts of money and used Warp speed and basically “saved the world”.
We did not receive a penny. The White House cannot claim they did anything to get Leronlimab to succeed. Is not a “convenient” therapeutics and is not what the political environment demands. It demands something that can be claimed as a triumph, as good management, as warp speed working, as COVID will be thing of the past yesterday.
This is not us and this is why I don’t like this announcement. A drug that probably is not ready, has not been probably fully tested (as FDA is now “deep state”) will be announced now because is convenient.
To the momentary detriment of the rest of us small companies playing by the rules who will have to wait until the science really confirms or not the drug that will get the “political” spotlight, as opposed to scientific idem.
I think REGN checks all the boxes. Received $450 Million from government, made a deal with Roche for production and the production has been already purchased. They got “adaptive” trials that can be manipulated and terminated before /full enrollment deadlines. And somebody wants them terminated before Nov 3.
Another possibility is to crown Remdesivir in spite of FDA and weak scientific evidence.
I surely hope I am wrong, and don’t want to make this a political post. Just trying to share my thoughts on why we should not feel optimistic about this announcement.
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