THE CASE FOR UNBLINDING CONT.
Excellent cases have been made many many people on this board for unblinding the data.
In pharma world (and in covid world) being first is everything. We just need hard data that FDA cannot ignore. 10's of thousands of more covid cases and thousands more deaths every day...
After getting burned with a few things he's said (regardless they should always do whats best from today forward), I'm afraid that Nader doesn't want to go back on what he said (about not unblinding the data), even if it is the better idea. Lets show him we support it and due some DD to prove our case!
So 6 of the best reasons for unblinding data are in the post (2-7). I'm replying to from RTB but I'll add them in.
I'm gonna add a few pros to the list that RTB and ohm20 have posted (I've been away from this thread this weekend so forgive me if there are more posts about unblinding) and hope that anyone else that can, add more reasons to unblund. When final, someone with a relationship to Nader can email it to him, perhaps Dr. Yo?
PROS FOR UNBLINDING
1. Saving thousands of lives of COVID patients between now and whenever we finish the trials, analyze the data, and wait 48 days for some reason.
2. The DSMC recommendation is a very strong indication that the p-value is very good. They feel it will could be great with 62 more patients, which could allow the trial to halt early... but time is not our friend.
3. Unblinding does not halt the trial. It causes us to take a penalty on the end-point p-value. Speculation is that the new required p-value would be .045 Current indications are that we are well below that now, so no reason we should fear that number if we add the next 62 patients or are somehow forced to go all the way to 390.
4. Unblinding would allow us to present the interim data to media, other scientists, FDA and other countries. Consider separating this reason into 3 reasons: (Media, FDA analyzes data now, Expediting decisions of other countries).
5. This data could help us generate revenue from product sales or from grants. We really need revenue. And, any approval will open the door for other opportunities. (2nd part is similar to PRO 15).
6. The recent approval of Remdesivir and the apparent efficacy of Dexemethasone (and the potential for the Regeneron EUA) are all going to make it harder to enroll or harder to differentiate the value of Leronlimab in trials.
7. The "risk" is low. As stated earlier, the p-value penalty is modest. If our current p-value is not great (e.g. right around .05), we might as well find that out now, rather than wait another 4 months. If it is at this level, it isn't likely to get better, as the higher number of patients is offset by the more challenging recruiting environment and improved care options.
8. The FDA needs hard data to give Leronlimab an EUA. (This would be giving the FDA hard data now where they would look really bad in ignoring when so many people are dying and aspirin is doing a better job than Remdesivir! (as someone else pointed out - sorry I don't remember who but I left the tab open) https://www.sciencedaily.com/releases/2020/10...195637.htm
9. We won't face an increasing SOC that could wipe out the statistical significance.
10. Potentially first to approval in severe/critical so we're not comparative to other drugs with a later EUA submission.
11. First to market with revenue to pay the bills and advance other trials.
12. Importance of being the first CCR5 antagonist for EUA approval cannot be underestimated. Dr. Lalazari explained in detail how hard it is to be compared to Remdesivir for doctors to recommend an unknown drug from an unknown company. Just imagine if it was the second CCR5 antagonist to BP after all the CCR5 hype has occurred with Maraviroc Currently Maraviroc is scheduled for a study completion date of January: https://clinicaltrials.gov/ct2/show/NCT04435522
Don't forget about CD24Fc and Cenicriviro. Yes LL has a better safety profile than Maraviroc and there might still be a use for it for COVID, but will they be as generous with EUA approvals after Eli Lilly and Regeneron get EUA approvals?? There's another reason right there, next.
13a. How many EUA approvals for COVID will they allow? POTUS wants to bury Covid under the rug (do you really think he wants to admit we need 5 EUA drugs for a virus he doesn't even want to admit the reality of?)
13b. Leronlimab still has competition even if they don't unblind and can prove in 3 months or so that is worked for 300-400 people. CD24Fc, Regeneron, Maraviroc, etc, so why not unblind now and have less competition for an EUA?
14. Will there be any spotlight left after the FDA and country have Remdesivir, Dexamethasone, Regeneron MABs, Maraviroc, Eli Lilly MABs (etc?) one more possible factor for Cytodyn to consider by waiting for data.
15. Branding/Helping other indications. Dr. Jay Lalazari spoke at length of how hard it is for Cytodyn's Leronlimab to compete with Remdesivir (works worse than aspirin) based on reputation of Remdesivir vs. "no" reputation of unknown drug or pharma co. - Just imagine how much the reputation of Cytodyn would improve if positive news of Cytodyn's unblinded data hit the world? This would be helpful in recruiting trial patients in ALL of Cytodyn's indications - https://investorshangout.com/post/view?id=5876607
16. Timing. Right now the best covid treatment that most people know about is something that pretty much only the president can get - Regeneron's antiviral cocktail. That won't last might longer. If Cytodyn could hit the world with positive coronavirus news at a time when the world is literally dying for positive news, how can we pass up that opportunity? In 2-4 months, the PR impact and first impression of Leronlimab to the world might just be “Maraviroc for those with liver issues”, rather than an answer of replacing a SOC - remdesivir, and maybe dexamethasone too if healthcare will still cover the cost after cheaper drugs become SOC (a possibility with Maraviroc).
17. Manufacturing - The greater the need when Leronlimab gets approved, the greater the support to manufacture. If we wait until it becomes a safer but way more expensive “Maraviroc” (Maraviroc study completion in Jan) how much government support will we get to quickly manufacture a supply to treat the country?
18. Cost. With 100s of thousands of people getting covid, how much can we guarantee EUA for a drug that helped 300-400 people by January to February but costs thousands of dollars more than the current SOC at that time? I heard that Maraviroc costs only $12/pill! Please fact check this. Dexamethasone - $8.78/patient - costs $8.78 per patient, according to IllumiCare, and it was given to 35.1% of hospitalized COVID-19 patients reviewed in July. -
CONS FOR UNBLINDING THE DATA
1. Small statistical penalty and the trial continues on. .005
THAT'S IT... THE LIST ENDS THERE (for now).
Is .005 really more significant than those 18 reasons? I don't even think its more significant than 1-3 of them. To not unblind, you have to think .005 added to the p value is more significant than all of the PROS together. (Currently 18).
If anyone can add to either the pros or the cons please reply copying this list so there is a master list we can email Nader by the end of the day. Its not about getting credit for adding to this list, its about getting 1 email in the hands of NP that is so convincing it gets his to reconsider:
ALL we have to GAIN by unblinding the data and
ALL we have to LOSE by not unbliding the data.
With that in mind, feel free to modify the wording of this list in any iteration (if others are interested in this endeavor that is). If not I will reach out to the brilliant minds of the board I have interacted with via PM, but I think we all can think of ideas. I've never taken a medical class or a busiiness class, and I came up with PROS 12-18.
I think is more worth our time than a sea of posts where he is unlikely to find the hidden gems. 1 well written email, polished email by the great minds of this board, just might get him to reconsider. And if here were to see this title used over and over on this board (all CAPS is eye-catching) he would see that many investors are behind this re-consideration of unblinding the data and that its OK to change your mind if it becomes the best thing to do moving forward.
Maybe we can forward the final email to Dr. Yo to add his insights and name recognition, asking him to send final email to NP. He can't believe the SOC/ state of the world and he loves leronlimab.
If we do this, a fun part can be when we agree about all the PROS and CONS and rate for priority (we want our most compelling PROS to be read first). I’ll be pretty busy tomorrow(today) but if someone doesn’t volunteer to do sort as rated we’ll figure it out.
LETS PUT TODAY'S EFFORTS TOWARD UNBLINDING THIS DATA.
After reading ohm20's and RTB's emails and thinking of the last few reasons in the last few hours, I can only imagine what we all are capable of doing together.
If we cannot use google for some reason:
Just copy and paste (newest post using all CAPS is most updated, not necessarily the best but should be if we only make improvements.
(My dad wrote all emails in all CAPS so this is an omage to him if thats how to say it.)
Feel free to use content in a previous post if you feel it was better.
So much easier/collaborative if we post comments here but keep master list on google so it can be edited by many people at the same time:
Don't forget there are shorts on this site. I made google doc so all with link can edit it... so at least Select All and Copy when editing in case its deleted while editing, and also download a copy when finished editing (and copy/paste to board with "THE CASE FOR UNBLINDING CONT. -YOURUSERNAME" as the title.
Pretty tired, so verbose in adding 12-18. Feel free to be more consice, combine 2 similar ones like I did for reason 12... whatever makes it better (for entire doc). Also, we don't need to edit until we get to PRO-140 (see what I did there?
, we should stop when a PRO is not a solid PRO. I'd like us to add the CONS too so this doesn't appear bias but that's the only con we know so far so please add whatever CONS you can think of.
Please take initiative if you agree the data should be unblinded now! Please help improve and execute this!
I don't know what you'd think but it would be awful to be on the sidelines after Cytodyn completes this trial due to any of the 18 or whatever PROS total not being considered worth a .005 statistical penalty and seeing a new landscape we do not fit into due to cost, manufacturing, ANY of the reasons (or some of them).
I cannot even believe we have to fight this hard to get the data unblinded. But we do, so lets fight. [b ]Ever wanted to save a life, here’s your indirect chance to help save thousands.
As we've learned, many unexpected things happen. Remdesivir even got approval and aspirin works better and is $1000s cheaper, practically free!!
The world can’t afford to wait until Leronlimab becomes the better but way more expensive Maraviroc. that most doctors still don't know about.
Since I could only reply to one post, I'm including the link to ohm20's post here: