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What is scary about it? It’s 4 days behind the news. 
As I look at it the HIV looks like a long shot based on this opinion. If the co-vid results are good there will be further delays getting the drug to market due to lack of safety data which would require phase three trial. Which leads to further delays to getting to market. Which allows further for a vaccine or other therapeutics to usurp CYDY.

So the play to me is IF the co-vid results are favorable, then ride the rocket for a short time and then get off before the realization hits that further trials and delays will occur.

That's the best I got at this time.

 
As I look at it the HIV looks like a long shot based on this opinion. If the co-vid results are good there will be further delays getting the drug to market due to lack of safety data which would require phase three trial. Which leads to further delays to getting to market. Which allows further for a vaccine or other therapeutics to usurp CYDY.

So the play to me is IF the co-vid results are favorable, then ride the rocket for a short time and then get off before the realization hits that further trials and delays will occur.

That's the best I got at this time.
I guess my plan is just to play it by ear if the covid results hit. Nothing matters if that’s a flop.  Personally I’m not thinking about the HIV aspect of this at all. Others may be, I dunno. 

 
Summary:  It's not good but it looks like it can be fixed in a reasonable period of time.  The delay is damaging to momentum but it's not likely to have long term significance.   :mellow:

'Out of Ignorance' rehashed old news and essentially cautioned investors about potential losses if things don't go well.  Well, okay.  Thanks 

 
Summary:  It's not good but it looks like it can be fixed in a reasonable period of time.  The delay is damaging to momentum but it's not likely to have long term significance.   :mellow:

'Out of Ignorance' rehashed old news and essentially cautioned investors about potential losses if things don't go well.  Well, okay.  Thanks 
Also highlighted likely limits of success in HIV arena due to partnership and competition.  That was news to me.

 
Netflix names Ted Sarandos co-CEO 

I know what that means, but, what does that mean?
It means that Hastings will be gone within a year. Co-executives don’t last long. If they name two people it, it usually means one of them will get it and the other leaves. This signals Ted will be the next CEO. So you normally could see some execs leave but I don’t think there’s a lot of people who were waiting to become CEO. CFO already left and Peters is young and have him a title. 
 

Hastings will ride off into the sunset and let Ted deal with actually having to make the company hugely profitable. Stock may be a down a bit on that inevitability as well. 

 
There was some discussion last night as to how good the CYDY severe-critical study has to be to be statistically significant.

Here's a link to a calculator.

Not sure I did this correctly, but I used a trial size of 90 with 12 deaths in both placebo and drug arms which translated into the following inputs:

Hypothesized Parameter 0

First Sample Size 30

First sample proportion 0.6

Second Sample Size 60

Second Sample Proportion 0.8

This results in a p-value of 0.0264 which makes it lower than 0.05 and significant.
Looks pretty good but it is important if you chose a one-sided test or a 2-sided test. If you did one-sided and they are doing two-sided, then a p-value of 2.6% becomes a p-value of 5.2% which just barely fails to be significant. One would assume they would use a one-sided test (duh) but the FDA or industry norms may have a say in that. I don't know what the standards are in that regard.

 
About a week or so ago I mentioned a friend that had made a nice haul with WKHS, and that he was looking at MARK. Told me today that he is definitely in for a nice chunk, especially after they had a big drop based on a bad earnings call. Says his group of investor friends see it as a 3x stock at this point.
Thanks, I've been following MARK since you mentioned it. Will do some due diligence and may dip a toe.

 
After hours trading indicates to me that there will be no big announcement in the morning:

16:00:05$5.491,000

16:00:05$5.481,750

16:00:02$5.48500

16:00:01$5.482,000

16:00:00$5.49600

 
As I look at it the HIV looks like a long shot based on this opinion. If the co-vid results are good there will be further delays getting the drug to market due to lack of safety data which would require phase three trial. Which leads to further delays to getting to market. Which allows further for a vaccine or other therapeutics to usurp CYDY.

So the play to me is IF the co-vid results are favorable, then ride the rocket for a short time and then get off before the realization hits that further trials and delays will occur.

That's the best I got at this time.
Couple of other thoughts. If vote passes, possible up coming significant dilution. (I haven't voted yet on this and thought I would follow Chet's lead.) Would effect SP negatively.

On other hand, if results are successful, odds increase of merger with a more experienced BP partner with big time resources.

 
Summary:  It's not good but it looks like it can be fixed in a reasonable period of time.  The delay is damaging to momentum but it's not likely to have long term significance.   :mellow:

'Out of Ignorance' rehashed old news and essentially cautioned investors about potential losses if things don't go well.  Well, okay.  Thanks 
Nothing burger

Nothing matters Other than the results of Covid.  

 
Out of Netflix for a $17 gain. Not bad for an after hours hunch. Best of lucks to you longs. I move that money into tza hoping Netflix drags down the market at open

 
I have walked away with a couple few thousand from cydy 3 times... on my 4th rodeo and I bought at 6.09.

Bring me another few grand you little internet stranger stock tip.

 
So who is jumping out if there is a gloryhole gusher up to $8 or $10 before trials results are released/leaked?
I hold 7500 shares now (couldn't help but buy a few more on the recent dip) and I'd definitely sell at $8, probably 1000 shares and another 1000 or 1500 at $10. If I'm left with a fat profit plus 5000 shares sitting at a share price of $10, that feels pretty good. I don't think I will ever be completely out. If it runs to triple digits, I do have a massive sell order already entered, but how could I not hold 100 shares in perpetuity for good measure? I can't quit you, CYDY.

 
So who is jumping out if there is a gloryhole gusher up to $8 or $10 before trials results are released/leaked?
If I hadn't had all my sells triggered on the day of reckoning a few weeks back I would be selling this time I think for sure at 10, probably even lower.

I rebought in for a much smaller position and will probably ride those out but $10 may be hard to pass up honestly.

 
So who is jumping out if there is a gloryhole gusher up to $8 or $10 before trials results are released/leaked?
40% before reveal? Can’t see that. 
 

And I am in for 15 or best. No guts no something yada yada 

 
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So who is jumping out if there is a gloryhole gusher up to $8 or $10 before trials results are released/leaked?
I'm in at an average of $3.05.  I will recover half my original investment at $9 or $10. I still want to have a little skin in the game.  Free-rolling is over-rated!

 
I do have a massive sell order already entered
I decided not to do that.  The idea that they couldn't short sell your shares if you had a sell order was a rumor that was never confirmed.  I don't want to waste 5 seconds taking off a sell order if I want to sell as a market order.  Every second can be precious.  I might put in a sell order for $9.96 so that I don't miss a pop followed by a short attack.

 
Expected timeline: 

Friday: Unblind 
"Following Week": Results 

Which probably means unblind next week and results in the first week or two of August with this squad :lol:  

Total guess, but suspect hospitals signed off on data before unblinding, otherwise could introduce bias. But probably totally wrong. @Whyatt likely knows protocol. 
The process for collecting clinical data is highly regulated and follows specific procedures to ensure it’s accurate. All data is “quantified” (a number, yes/no, etc.) and double checked. Assuming data is paper based, it’s entered into a validated program twice and checked for a perfect match. Once all this blind data is verified, it is locked in the database, then unblinded.

Once unblinded, top line results pop out quickly. Depending on how the database is set up, a more nuanced view of the data can take a bit more effort.

 
The process for collecting clinical data is highly regulated and follows specific procedures to ensure it’s accurate. All data is “quantified” (a number, yes/no, etc.) and double checked. Assuming data is paper based, it’s entered into a validated program twice and checked for a perfect match. Once all this blind data is verified, it is locked in the database, then unblinded.

Once unblinded, top line results pop out quickly. Depending on how the database is set up, a more nuanced view of the data can take a bit more effort.
Will they wait to do the full review of the data or push out the topline result ASAP?

 
I decided not to do that.  The idea that they couldn't short sell your shares if you had a sell order was a rumor that was never confirmed.  I don't want to waste 5 seconds taking off a sell order if I want to sell as a market order.  Every second can be precious.  I might put in a sell order for $9.96 so that I don't miss a pop followed by a short attack.
Mine is a limit order to sell 5000 shares at $99.90. I’m not losing sleep over that, I don’t really care about shorts, and I almost never place market orders. 

 
The process for collecting clinical data is highly regulated and follows specific procedures to ensure it’s accurate. All data is “quantified” (a number, yes/no, etc.) and double checked. Assuming data is paper based, it’s entered into a validated program twice and checked for a perfect match. Once all this blind data is verified, it is locked in the database, then unblinded.

Once unblinded, top line results pop out quickly. Depending on how the database is set up, a more nuanced view of the data can take a bit more effort.
Do you know if the 5% threshold for p-values is uniformly used or if one-sided tests are strong enough to be used? Thanks for your posts. 

 
If this article doesn't scare the beejesus out of you re: CYDY......

https://seekingalpha.com/article/4358911-cytodyns-bla-blues
Here is at least one of the things that triggered Feuerstein.

FDA asked for further safety study of the 700mg dose early last year, and it seems pretty clear they wanted the data in the BLA. Cytodyn submitted the BLA without the data, as it wasn’t ready. Did CYDY really think they would get anything other than a RTF? 

This data would be needed for any Covid filing.

Issues like this are why this company has the reputation it has in the industry.

 
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Do you know if the 5% threshold for p-values is uniformly used or if one-sided tests are strong enough to be used? Thanks for your posts. 
Remember this is phase 2. 5% will absolutely get FDA to agree to a phase 3 study. I think the data needs to be much stronger for EUA

 
Hear me out on this before saying I’m crazy.

We all know Trump can’t let big positive Covid news come out with at first teasing something out...like he did last week alluding to the mrna vaccine news.

If he teases something out...double down on cydy

If we hear nothing and get a bit of a price run over next three business days then de-risk by cob tues

Crazy?

 
Remember this is phase 2. 5% will absolutely get FDA to agree to a phase 3 study. I think the data needs to be much stronger for EUA
The only thing they have going for them is that the rest of the world will see the results.  There is definitely countries with lower standards that will approve decent results even if the FDA wants a phase 3 study.  Good, but not great results, will make it difficult for the FDA.  I am not sure what they will do.  They definitely would not want a drug with better efficacy than Remdesivir to be going to other countries.

 
The only thing they have going for them is that the rest of the world will see the results.  There is definitely countries with lower standards that will approve decent results even if the FDA wants a phase 3 study.  Good, but not great results, will make it difficult for the FDA.  I am not sure what they will do.  They definitely would not want a drug with better efficacy than Remdesivir to be going to other countries.
Good point. itolizumab just was approved in India after a 30 patient trial. Looks like it will be studied in the US, but no EUA. 

Good results would absolutely accelerate a potential phase 3. With the right support you can fill a 400 patient trial in a month.

 
What are the primary endpoints of the M2M?
This Phase 2 trial evaluates clinical improvement of several symptoms over a 14-day period, including changes in multiple clinical baseline metrics after days 3, 7 and 14.  The Company expects the evaluation clinical patient data to be available two weeks after the last patient is enrolled. Because there are more patients who have been screened for enrollment, final enrollment is expected to exceed 75.
 

IDK, seems vague. I understand how the drug calms the cytokine storm (which could be more severe cases), but what about basic cough, cold, shortness of breath, fever, etc?

What’s the MOA for that?

 
Good point. itolizumab just was approved in India after a 30 patient trial. Looks like it will be studied in the US, but no EUA. 

Good results would absolutely accelerate a potential phase 3. With the right support you can fill a 400 patient trial in a month.
Great. We can go from 140000k dead to 250000k while they jerk off. We’ll probably have heard immunity by the time a vaccine and/or treatment are approved 

 
Any BABA owners in here? Looking to add some to my portfolio and noticed the insane 1 year target prices on Yahoo, currently mid $200's with targets in the $2k range. :lmao:

Anyone like BABA?

 
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Great. We can go from 140000k dead to 250000k while they jerk off. We’ll probably have heard immunity by the time a vaccine and/or treatment are approved 
CYDY stockholders universally like this post. I get it.

First, let’s see what the results say. Next this is mild/moderate, I’m interested in to know the fatality rate, my bet is it’s low.
CYDY does have a pivotal trial ongoing, but it’s filling pretty slowly.

 
Yea, but if we’re unsure of the MOA, wouldn’t we have more confidence in the severe and less in the M2M? 
I'm probably missing something, but for me, not at all. There was something from Dr. Patterson about reducing viral load, which to my untrained ear sounds pretty handy for either indication. 

 

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