Here it is... Where we are and where we are goi
Post# of 153880
(Total Views: 514)
Posted On: 10/16/2020 11:12:05 AM
Here it is...
Where we are and where we are going:
Where we are...
“Management will discuss the recommendations of the Data Safety Monitoring Committee (DSMC) following their review of the interim analysis of the first 195 patients enrolled in the Company’s Phase 2b/3 clinical trial for patients with severe-to-critical COVID-19 indications, including a potential regulatory path forward.”
This is obviously the key paragraph. DSMC and path forward in the same paragraph. This says to me rule out a failure for SAE or efficacy. IF failure THEN immediate announcement and certainly no mention of DSMC.
This leaves us with:
1. Halt for amazing results. I doubt this for statistical reasons. I also doubt this because there are other avenues open to the FDA (EUA for instance) that would allow use of drug but see the study go to completion.
2. Continue study. I gave it a 66%-75% chance that this would be the case(25% chance halt for superior efficacy) which I think is just fine as it allows for a more accurate result while there are no real contenders (remdesivir has been disproven) to destroy Cytodyns chances.
Where we are going...
Assuming the above is correct I predict that we will get a “continue with study” from Nader with an EUA teaser. I think that is ok.
1. It may negatively impact share price (short term sell off on no news) but it may bolster it (shorts don’t want to be caught...EUA threat)...at the end of the day I say “so what”. After asking a number of investors the share price on HIV alone is $7-$13 a share.
2. If “continuation of study” then national coverage for sure (IMO) as well as the possibility of step up for HIV BLA timeline.
3. Also doses on hand is an additional threat.
4. But most importantly the messaging is “will / could meet endpoint” with no other immediate contenders in sight and with remdesivir fail is MM back on the table?
What I don’t like...
NADER. The problem isn’t what he is or isn’t doing (although those problems are plentiful) ...the real problem is HIM. He has zero street cred in the medical community...zero street cred with the government and (along with a less than squeaky past...sorry it is a factor) crummy optics. He made up for this by distancing the company from those that actually have said cred.
Let’s see what happens Tuesday. I will be a holder if the above plays out as I “hope”.
Where we are and where we are going:
Where we are...
“Management will discuss the recommendations of the Data Safety Monitoring Committee (DSMC) following their review of the interim analysis of the first 195 patients enrolled in the Company’s Phase 2b/3 clinical trial for patients with severe-to-critical COVID-19 indications, including a potential regulatory path forward.”
This is obviously the key paragraph. DSMC and path forward in the same paragraph. This says to me rule out a failure for SAE or efficacy. IF failure THEN immediate announcement and certainly no mention of DSMC.
This leaves us with:
1. Halt for amazing results. I doubt this for statistical reasons. I also doubt this because there are other avenues open to the FDA (EUA for instance) that would allow use of drug but see the study go to completion.
2. Continue study. I gave it a 66%-75% chance that this would be the case(25% chance halt for superior efficacy) which I think is just fine as it allows for a more accurate result while there are no real contenders (remdesivir has been disproven) to destroy Cytodyns chances.
Where we are going...
Assuming the above is correct I predict that we will get a “continue with study” from Nader with an EUA teaser. I think that is ok.
1. It may negatively impact share price (short term sell off on no news) but it may bolster it (shorts don’t want to be caught...EUA threat)...at the end of the day I say “so what”. After asking a number of investors the share price on HIV alone is $7-$13 a share.
2. If “continuation of study” then national coverage for sure (IMO) as well as the possibility of step up for HIV BLA timeline.
3. Also doses on hand is an additional threat.
4. But most importantly the messaging is “will / could meet endpoint” with no other immediate contenders in sight and with remdesivir fail is MM back on the table?
What I don’t like...
NADER. The problem isn’t what he is or isn’t doing (although those problems are plentiful) ...the real problem is HIM. He has zero street cred in the medical community...zero street cred with the government and (along with a less than squeaky past...sorry it is a factor) crummy optics. He made up for this by distancing the company from those that actually have said cred.
Let’s see what happens Tuesday. I will be a holder if the above plays out as I “hope”.
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