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FDA its again upto you... now! 90 days could be 90,000 lives . Donot delay this again!
Lets all tweet this now!
The fact that we are allowed to continue is clear indication we are safe And perhaps efficacious than placebo even if not statistically significant yet with the population considered. Connsidering that placebo is probably remdesvir would this not be enough for FDA to make LL the standard of care where remdesvir does not work by day 14 or what happened to the secondry end point?? What if LL improved symptoms at day 14 more than standard of care?? Sounds like FDA could ask LL to be used on certain patients for sure IF they consider that this is a pandemic. I am assuming LL improved symptoms by day 14. We would not know until end of trial.
4.4.1.1. Monitoring for Effectiveness
In studies with serious outcomes, all parties would wish that any major treatment advance be identified and made available as soon as possible. It is critical, however, that the study yield a valid and definitive result. Thus, tensions between ethical and scientific considerations may arise. Consider, for example, a placebo-controlled trial of a new product for a serious illness or condition for which there is no standard treatment. If the emerging data suggest that those receiving the treatment are doing better, one might expect that a DMC would consider whether the study should be terminated earlier than planned. Estimates of treatment effect, however, will be unstable at early points in a study, and the chance is substantial of observing a nominally statistically significant benefit (e.g., p<0.05) at one of multiple interim analyses during a study of an ineffective product (see Section 4.4.2). A DMC, guided by a pre-specified statistical monitoring plan acceptable to both the DMC and the study leadership, will generally be charged with recommending early termination on the basis of a positive result only when the data are truly compelling and the risk of a false positive conclusion is acceptably low.
A second type of consideration is whether the hypothesized benefit is likely ultimately to be achieved. If the interim data suggest that the new product is of no benefit—that is, there is no trend indicating superiority of the new product—or that accrual rates are too low or noncompliance too great to provide adequate power for identifying the specified benefit, a DMC may consider whether continuation of the study is futile and may recommend early termination on this basis. In this case, false negative conclusions are of concern; statistical procedures are available to guid
Everyone questioning the basic efficacy of LL should be onboarding the LL train now.
You wanted a third party (dsmc) to determine the efficacy and they asked For MORE DATA. Period.
As it says in the PR , dsmc could hav asked us to stop the trial under the “futile” option but nooooo they did not.
They just asked for 42 day so it (obviously) will show a marked improvment of LLs efficacy over Placebo. And make p<.05 (take out ‘chance’ ). One can survive for more than a month on placebo but perhaps not longer. If you doubt, google sp balasubramanian a famous singer from india who died recently due to covid but was OK in the hospital for around a month doing well.
An approval “delay “ now is hardly anything for CYDY in the medium to long term even just in terms of Covid as the “endemic” potentially would be a thing we live with for years and LL will be something may be even bears have to take a shot of some day wink wink
I am sad that in the 3 months we could have been approved (now vs Jan) several thousands will be sick and die
But happy i hold cydy ( sad i couldnt buy more at 30 cents lol but ok)
A LL approval WHENEVER is going to make a HUGE impact to millions for years just as Teraflu or Tamiflu is!
“Covid-19 likely to become as ‘endemic’ as annual flu virus
Covid-19 is likely to become as “endemic” as the annual flu virus, the U.K.’s chief scientific advisor said.
“We can’t be certain, but I think it’s unlikely we will end up with a truly sterilizing vaccine, (that is) something that completely stops infection, and it’s likely this disease will circulate and be endemic, that’s my best assessment,” Patrick Vallance told the National Security Strategy Committee in London on Monday.
“Clearly as management becomes better, as you get vaccination which would decrease the chance of infection and the severity of disease ... this then starts to look more like annual flu than anything else and that may be the direction we end up going,” he said.
A vaccine against the new coronavirus — and there are a handful in Phase 3 clinical trials, according to the World Health Organization — is not likely to eradicate the virus anyway, Vallance added. —Holly Ellyatt”
Posted this to Mike
Question: Are we /could we consider a collaboration with another Pharma perhaps a big pharma to accelerate trial enrollment, leverage their resources, etc for Covid S2C? Perhaps a pharma which is NOT in the race for a Covid thereputic is a good suggestion.
If you note, few of the smaller vaccine pharmas have collaborated with bigger pharma.
Remember that Covid play was an inadvertent one. But getting approval for covid (whenevr) WILL make it way easier to persue more than one regulatory pathway as a treatment for others (hiv, cancer,nash,etc) since it would be a proven drug and the whole notion of a new small pharma with a new drug would have gone by then.
Refer to the link i fwded earlier on a potential pathway a drug already in the market can use.
If we dont hav the patience to put up with a small pharma its not cydys problem. Covid is and is going to get very bad and without a vaccine in sight for months years may be. Getting LL an appproval is still on the cards by new years or end of Jan 21.
It will still be the only treatment even then wouldnt it be
The latest PR is the first PR this year that has been released after hours (8 pm PT).
I see lots of positive important PRs at 6 am eastern ie 3 am pt which could be considered late hours.
Point is there was a need felt to release the PR that night rather than next day morning.
Usually when you have not so happy news you CAN wait till next day to release a PR cant you lol
Just speculating :
Np receives the writtten letter from dsmc at 7:55 pm pt
He is elated or sad and asks his assistant to write a PR at 8 pm pt wink wink
Or np receives the written letter with not so happy news in the morning
Waits till 8 pm pt to release a PR? That is not np!
More plausible first scenario and more likely happy scenario!
Apologize for another copy paste. If we did not already know, dsmc nembers appear to be selected by cydy. So you would think they would select ppl with some nice background and common sense and highly recognized:
DMC ESTABLISHMENT AND OPERATION
4.1. Committee Composition
The selection of DMC members is extremely important, as DMC responsibilities relate to the safety of trial participants. A poorly constituted DMC may fail to note problems that should be addressed, or may make recommendations that are unwarranted or whose consequences are inadequately considered, thereby undermining the safety of participants as well as the value of the trial. The ability of DMCs to provide the anticipated additional assurance of patient safety and trial integrity therefore depends on appropriate selection of DMC members.
The sponsor and/or trial steering committee generally appoint members of a DMC. Factors to consider in the selection of individuals to serve on a DMC typically include relevant expertise, experience in clinical trials and in serving on other DMCs, and absence of serious conflicts of interest as discussed below. The objectives and design of the trial and the scope of the responsibilities given to the DMC determine the types of expertise needed for a particular DMC.
Most DMCs are composed of clinicians with expertise in relevant clinical specialties and at least one biostatistician knowledgeable about statistical methods for clinical trials and sequential analysis of trial data. For trials with unusually high risks or with broad public health implications, the DMC may include a medical ethicist knowledgeable about the design, conduct, and interpretation of clinical trials. Prior DMC experience is important when considering the committee as a whole; it is highly desirable that at least some members have prior DMC service. Prior DMC experience is particularly important for the statistical DMC member if there is only one statistician serving on the DMC.
Some trials may require participation of other types of scientists. Toxicologists,
Since someone wanted me to go beyond copy paste...
“ including a potential regulatory path forward.”
No one i saw so far commented on the “a” .
This could have been “the” but they choose “a”. No big deal.
But if you read the sentence with a “the” it sounds neutral, normal PR like.
If you read it with an “a” it makes it sound like cydy HAS “a” potential regulatory path forward in mind.
I bet the potential regulatory pathway for cydy is in here hidden between a EAU and CTAP:
https://agencyiq.com/the-twenty-two-regulatory-pathways-the-fda-is-likely-to-leverage-to-get-new-covid-19-therapies-to-patients/
I am no expert lol i look for authentic sources read up tell my opinion. The article is in fda.gov for all to see and interpret (smile)
I just do not see anywhere dsmc could recommend anything other than stopping the trial as it relates to efficacy:
Potential DMC Responsibilities
4.4.1. Interim Monitoring
Most experience with DMCs has been in the setting of studies that address major outcomes such as mortality or serious irreversible morbidity. Although many such studies focus on short-term endpoints such as 30-day survival, other studies often use endpoints that require a substantial duration of follow-up after the intervention delivery has been completed. The need for monitoring in such
16
Contains Nonbinding Recommendations
studies often extends beyond the time when individuals are treated, since trends in survival or other serious outcomes may not become evident until some time during the follow-up period. Thus, the DMC’s responsibility to monitor the study generally continues until the planned completion of follow-up, regardless of the duration of treatment.
4.4.1.1. Monitoring for Effectiveness
In studies with serious outcomes, all parties would wish that any major treatment advance be identified and made available as soon as possible. It is critical, however, that the study yield a valid and definitive result. Thus, tensions between ethical and scientific considerations may arise. Consider, for example, a placebo-controlled trial of a new product for a serious illness or condition for which there is no standard treatment. If the emerging data suggest that those receiving the treatment are doing better, one might expect that a DMC would consider whether the study should be terminated earlier than planned. Estimates of treatment effect, however, will be unstable at early points in a study, and the chance is substantial of observing a nominally statistically significant benefit (e.g., p<0.05) at one of multiple interim analyses during a study of an ineffective product (see Section 4.4.2). A DMC, guided by a pre-specified statistical monitoring plan acceptable to both the DMC and the study leadership, will generally be charged with recommending early termination on the basis of a positive result only when the data are truly compelling and the risk of a false positive conclusion is acceptably low.
A second type of consideration is whether the hypothesized benefit is likely ultimately to be achieved. If the interim data suggest that the new product is of no benefit—that is, there is no trend indicating superiority of the new product—or that accrual rates are too low or noncompliance too great to provide adequate power for identifying the specified benefit, a DMC may consider whether continuation of the study is futile and may recommend early termination on this basis. In this case, false negative conclusions are of concern; statistical procedures are available to guide such determinations
More to show dsmc would not recommend end point change etc
2.3. Will a DMC Help Assure the Scientific Validity of the Trial?
A third consideration in the decision of whether to have a DMC for a trial is whether a DMC can help assure scientific validity (and perception of such) of the trial. Trials of any appreciable duration can be affected by changes over time in the understanding of the disease, the affected population, and the standard treatment used outside the trial. These external changes may prompt an interest in modifying some aspects of the trial as it progresses. When a DMC is the only group reviewing unblinded interim data, trial organizers faced with compelling new information external to the trial may consider making changes in the ongoing trial without raising concerns that such changes might have been at least partly motivated by knowledge of the interim data and thereby endanger trial integrity. Sometimes accumulating data from within the trial (e.g., overall event rates) may suggest the need for modifications. Recommendations to change the inclusion criteria, the trial endpoints, or the size of the trial are best made by those without knowledge of the accumulating data (with the exception of changes the DMC might recommend on the basis of emerging safety concerns, as discussed in Section 4.4.1.2). When the trial organizers are the ones reviewing the interim data, their awareness of interim comparative results cannot help but affect their determination as to whether such changes should be made. Changes made in such a setting would inevitably impair the credibility of the study results. This problem will be addressed more fully in
7.3. DMC Recommendations for Protocol Changes
A DMC may, in some instances, recommend changes to the study protocol, particularly in the context of their responsibilities for monitoring patient safety. Many protocol changes have little impact on the usefulness of a trial to gain regulatory approval. Certain types of changes to the protocol, however, such as changes in the primary endpoints, could have substantial impact on the validity of the trial and/or its ability to support the desired regulatory decision if they potentially could have been motivated by the interim data. We recommend that sponsors discuss proposed changes of the latter type with FDA before implementation.
We donot have any safety issues so highly unlikey that dsmc recommended an end point change based on efficacy. Not their job duty listed.
From several articles read, does not appear that a dsmc ‘s role is to recommend chg in end points.
There is seperate IRB cydy had to employ for that.
Other than that it appears the efficacy recommedations are stop of the trial (for good and futile reason) Or continue the trial. Continuing itself means they expect us to hit our end points. Otherwise we would be asked to stop due to the futile clause. Secondly, dsmc may have recommended this but fda could revisit this. See below how even stopping a trial recommended by dsmc is recommended to
Be reviewed by the fda before doing so.So we could be in this bucket too. Thats why no PR until FDA and cydy discuss about the implications of stopping the trial:
7.2.1. DMC Recommendations to Terminate the Study
In almost all cases, a DMC is advisory to the sponsor; the sponsor decides whether to accept recommendations to discontinue a trial. FDA will rarely, if ever, tell a sponsor which decision to make. For trials that may be terminated early because a substantial benefit has been observed, however, consideration may still need to be given to the adequacy of data with regard to other issues such as safety, duration of benefit, outcomes in important subgroups and important secondary endpoints. We recommend that sponsors of trials that could potentially be terminated early for efficacy reasons discuss these issues with FDA prior to implementing the trial, when the statistical monitoring plan and early stopping boundaries are being developed. In these settings, consultation with FDA may provide the sponsor with important information regarding the regulatory and scientific implications of a decision and may lead to better decisions. Sponsors are encouraged to revisit these issues with FDA when considering DMC recommendations for early termination if new issues have arisen and/or if the regulatory implications of early termination were not adequately clarified at the outset of the trial.
7.2.1. DMC Recommendations to Terminate the Study
In almost all cases, a DMC is advisory to the sponsor; the sponsor decides whether to accept recommendations to discontinue a trial. FDA will rarely, if ever, tell a sponsor which decision to make. For trials that may be terminated early because a substantial benefit has been observed, however, consideration may still need to be given to the adequacy of data with regard to other issues such as safety, duration of benefit, outcomes in important subgroups and important secondary endpoints. We recommend that sponsors of trials that could potentially be terminated early for efficacy reasons discuss these issues with FDA prior to implementing the trial, when the statistical monitoring plan and early stopping boundaries are being developed. In these settings, consultation with FDA may provide the sponsor with important information regarding the regulatory and scientific implications of a decision and may lead to better decisions. Sponsors are encouraged to revisit these issues with FDA when considering DMC recommendations for early termination if new issues have arisen and/or if the regulatory implications of early termination were not adequately clarified at the outset of the trial.
For trials that may be terminated because of safety concerns, timely communication with FDA is often required (see, e.g., 21 CFR 312.56(d) (drugs
If the DSMC recommends changing the endpoint I wonder if management could then unblind the data and request EUA immediately should either of those secondary endpoints have a high degree of statistical significance from the treatment arm over placebo???
-From Another Blog
"So they're only answering questions submitted in advance. That leads me to believe that there will have to be a press release on Tuesday pre-market at the latest. Otherwise there's no way to ask about anything revealed on the conference call since the questions will have to be submitted BEFORE the call even occurs."
-Another blog
“Note: Subject who were prescribed (1) hydroxychloroquine or chloroquine with or without azithromycin, (2) Remdesivir, (3) convalescent plasma therapy, or (4) immunomodulatory treatments (including but not limited to sarilumab, clazakizumab, tocilizumab, and anakinra) for the off-label treatment of COVID-19 prior to study enrollment may be included and may continue to receive these agents as part of standard-of-care”
Clinicaltrials.gov shows under LL ‘s s2c trial
It will be interesting to see if we actually enrolled any such patients and actually saw their primary and secondary outcomes improve.
BP meeting with cydy right now IF interim results s2c trial is being asked to continue by dsmb.
Whether they want to invest on a minority investment or BO, we shall wait and see.
Approval for LL is an eventuality now. FDA needs to make sure they get the “experts” from bp to sign off on the results. This will happen by the time we finish up
S2c. ALL GOOD!
See below article on all the types of regulatory pathways.
LL if not EUA path may go for accelerated approval under CTAP program.
It appears that once given EUA it could be difficult to get regular approval (we so want LL to be the cure for Covid and not just uaes for emergencies):
“EUAs typically are not authorized with significant clinical data or assurances as to their safety or efficacy, and it can be difficult to convert an EUA to a full approval, as use of a product under an EUA doesn’t lend itself to collecting the type of clinical evidence needed to support full approval. Very few drugs or biological products qualify for this authorization pathway, though it is used extensively for medical devices and diagnostics, which generally present less risk to a patient. A sponsor is under no obligation to sell the product authorized for use, and the FDA is not able to compel them to do so.”
“ Pathways specific to COVID-19
Coronavirus Treatment Acceleration Program
What it is: A “special emergency program” intended to accelerate the review of therapies intended to treat, cure or prevent COVID-19. The review program “uses every available method to move new treatments to patients as quickly as possible.” The pathway combines many elements from other review programs and pathways listed below, such as rolling review, accelerated timelines, hands-on support from FDA review staff and more.”
https://agencyiq.com/the-twenty-two-regulatory-pathways-the-fda-is-likely-to-leverage-to-get-new-covid-19-therapies-to-patients/
The fasting growing biotech with the highest returns in the last year. Aham. Remember that if LL was not persued for Covid at all what would you be complaining about? That the stock is stuck at 30 cents right? Now 10x but still if you are complaining then obviously your iq is questionable lol
Every step forward will pay. Its not for nothing that other nations (UK, europe, asia) were aggressively persued months back. Obviously np knows hurdles in the US are plenty(legal
And illegal). As we all hav said the moment one country is happy with our efficacy, US is going to follow suit to appear politically correct. Until then they (have to’) love bp bcoz they been paid lobbied.
All this assuming Np is not throwing a double bluff with the usual PR on Friday CC Tue/Wed thingy hehe!
The fact that dsmb has potentially asked to finish the trial is the first real validation that LL is in the right track in hitting the primary end points and being the cure! Until now we had only eInd 60 patients. I was always positive but waiting for dsmb to either ask the trial to stop for compassionate reasons for the placebo arm or to give the ok to continue the trial to before i loaded up
More shares! again with only 45 dead in the interim and going by the standard mortality rate of s2c patients..LL
Seems to ve mirroring the eInd results !!!!
More shares!
Cant wait to hear the PR -Cytodyn’s S2C interim analysis shows LL has 50% mortality rate over placebo arm”????????????
I listened to it again. He says “hopefully “ the first time and the second timw at the end says “end of next week WILL be a big day”. But i think we get the idea. He just should release the PR without building it up. He thinks it benefits the shareholders to know what he knows at any point (mostly) but that often leads to the opposite of the intended outcome
D DAY YET ??? Excited! Just a thought losing money in the markets is not just on the company! Timing is everything!
Interim analysis for s2c should have started last week. We reached 195 patients in Aug 25 (PR). 28 days from that was last week!
Its past noon in UK now and will be evening when we hit market’s noon. Expect a short PR sometime before close??
We will be up 25% tomm
IFFF this Cc also ends up as a nothing burger then for sure np
And the investor relations at Cydy is snoozing. Ifthere are no updates just talk about creative micro. Enough of nothing burger updates. This pandemic time and huge shorting time just release material news please. No news normal. Nothing burger news is/can be misconstrued as cover up.
Tweeted Megan from cnbc who says today AZN and Vir bio are the first to test antibodies on humans.
Not sure if she means monoclonal or the plasma antibodies.
Basic human psychology: break bad news asap , make people wait for gud news/ build it up and then kaboom
Why not announce a CC today tomm instead of 3 days later??
Right?
Another stock i own did this and it so happened they had gud news but yet to receive the full details which they did in the interim before the CC
If it was a HUGE news (gud or bad) and confirmed i would think CC wud hv happn today
I just think they have regular updates like awaiting final status, responded to comments and most interesting
Is the creative micro presentation. It may be the actual highlight to show off our cancer potential.
Every other update (unless received today tomm) may turn out to be a few more excruciating waiting days
In Uplisting it is not even fair to compare apples to apples but fyi Nextec AR filed for nasdaq uplisting a week before us (Jul 9 ) and they are still fulfilling answering questions. I am sure we see too. After we answered theur questions we are in the 2 week period perhaps fir nasdaq to respond
“Potential approval “ means all is well ! Perhaps fda has responded with a timeline “will get back within 2 weeks” kind of thing
My guess: Rem ‘s expanded usage has to do something with LL’s approval. Lets see. Have a great weekend folks!