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When?
I fear if no more info until CC, then sp will tank. I am hopeful that CC will provide a little more info regarding severe, and timelines of when is an EUA applied for, then sp may go up until then.
If FDA doesn't give EUA, do you think another country will? I would like to see that, but I think politics plays a big role in this, and I have my doubts that another country will give EUA if FDA doesn't, just saying.
When do you think EUA is given? I thought the 2 weeks FDA had data would be so they could expedite if it was beneficial. 24% increase in critical lives saved seems beneficial. Shouldn't any EUA be coming forthwith?
Will EUA for critical be given? More data required for severe and possible full approval? Is this a possible outcome? What are revenue possiblities in this case?
Main question! Will this get CYDY EUA? Will there be sales in UK, Canada, and Brazil, Mexico and the Philippines? Will there be revenue?
I hope NP doesn't say "soon" at end of next week. Then stock would crater for sure.
Thank you SF Anony. I believe you are right, but for me the risks and questions remain. FDA has known all along the efficacy due to OLE and eIND. I think that they could have given EUA right away once they received data. They didn't. Discussions regarding distribution etc do not hinder EUA. That can be decided after the fact. Hence for me I've reduced my exposure because I think FDA will not give CYDY outright EUA, only that that CYDY will have to pony up and play ball with a big BP and sell to them at a reduced rate to get it to market through their distribution channels. Less revenue to impact BP's bottom line and they get a big cut.
I hope and believe you are right. I just read the tweet that the long hauler trial protocol was approved. I don't see how that could happen if FDA didn't think that leronlimab had some benefit, hence EUA imo.
So we can expect FDA to try to find a way not to give EUA? What would be grounds for FDA to do this? I was hoping FDA cares more for lives than money.
Thank you, do you think they might try to limit it to s/c so as to perhaps limit revenue and keep CYDY beholden to FDA for further approvals?
Misiu143 I get the feeling from this post you have no faith at all in FDA. Would you go so far to say that Fauci controls the narrative, and unless "stat sig" there will be no EUA? Is the FDA that much in BP's pockets? Even if EUA given there will be protocols that CYDY will have to follow, that FDA will try to limit the best they can any revenue from leronlimab? In other words, you don't think EUA if given will be a big material event?
What tactic will shirts use if EUA given before the end of the month? I really believe that leronlimab is the answer not only for covid19, but many other indications as well. Why would individuals cast dispersion on a medical breakthrough that could save millions of lives, simply for their own profit? If EUA is granted, then it is downhill from there for many others to gain access to leronlimab and healthy living, what tactic will shirts use to try to keep the price down, and slow the ability of CYDY to get out this treatment?
I believe you are right. I think that until numbers such as revenue for Jan are released, we don't move much. I wonder if policy has changed regarding this starting this year, as they had been releasing revenues on a monthly basis until now.
I believe you're right. I have no medical knowledge, but just from a common sense point of view, I am sure FDA is very aware of the problems that varients pose. It appears that FDA wants to make sure that it can work on them as well. Can you just imagine the sales around the world when it is clear leronlimab is the ONLY therapeutic that stops covid19!
It works! OLE and eIND are still ongoing a week after FDA received the raw data. I wonder why people can't see that. If you're short because you think it will not get EUA, then you're going to get burned. Let's be honest, the FDA is probably holding NP's hand walking him through this. But I think they want this to happen as much as we do.
I think until we see some numbers, we're going to see this kind of trading regardless of the pr. It's going to rocket when it does, we just have to be patient.
I like the "improve margins" part of the pr.
What about the part about if approved sales would start in early 2021?
Has BLA been filed for HIV? In the first paragraph it states this. I hope this portends good things to come.
NP stated 2-3 weeks for discussions. Could it be shorter or longer? I hope shorter.
Thank's for your reply. Variant's may also be a factor as some appear resistive to vaccines. What you say regarding FDA sounds logical as they may be between a rock and a hard place with something to show to the American people. I sincerely believe leronlimab is a wonder drug, and it is what will turn the tide of covid 19 if given the chance. Then on TO HIV and cancer.
I hope and believe you are right. The wording stating the results have been unblinded and that they are in ongoing discussions with regulators, doesn't sound as if they are analyzing data. It sounds as you aptly put it. My question is because I'm very nervous about FDA and their motives, would they try to limit leronlab? They have already given Lilly m/m, and I think since CYDY owns the data, if it hit primary I have a hard time seeing NP not putting that in a pr. If they didn't I can see FDA saying let's all get our heads together and come up with a solution, which is possibly a EUA for only S/C since so many secondary endpoints were met, it had shown to be beneficial to these people. I still believe CYDY sells a lot of leronlimab, but not infringing on the BP's market.
If EUA from all countries, and there are nunbers as far as who gets how much, and a time frame, that means revenue! If that happens I hope we hit double digits if that kind of announcenent is made.
But I hear there is a new strain in Calif that is resistant to antibodies developed by the vaccine. Along with the UK variant, it's possible this could start over.
Glad to see the needed correction. This pullback and gap filling will provide a better base to build on. It may finish over $2 this week or not, but I believe it will end the year over $10. Go IQST!
When will we get Jan revenues? I would like to see an increase over Dec. Not too worried about income right now with debt gone, it will come.
I am very very long. I have more invested in CYDY than any other stock, more that my wife thinks I should. If it tanks, then I will be ok, but just ok. I am nervous about the things that the FDA has put on CYDY in the past, and have seen NP not handle the on goings of CYDY well, but I believe that the science of leronlimab can save millions of lives. Yes I am nervous, but very hopeful.
misiu143, Rockleo, thanks, it's just that over the course of this pandemic we have seen different BP's tout their therapeutics, or vaccines, and have said the efficacy was this or that, and are now in conversations with FDA about EUA. I am not well medically versed enough to know why CYDY could have not had the same approach. I understand that there is a confidentially agreement, however why would that be? Is it possible that FDA wants to handcuff CYDY, and they don't want the results known that would put them in a bad light? Is it some way that BP can control CYDY? I have no faith in FDA, even though many have said not to think like this, but I have seen nothing to persuade me to think otherwise. I am extremely hopeful that CYDY is given the green light, not only from a share holder's point of view, but for the many lives that can be saved.
misiu143, Rockleo, since you have medical proficiency, why could NP not say that they were talking about EUA in PR, rather than just in negotiations with the different agencies? Other companies have said that after completed trials, and if unblinded would NP not know the result? The 2-3 weeks that are mentioned are not for data analysis, rather negotiations, so the results are known, why not say, we know the results and we are talking about a EUA with these agencies, isn't what they are doing? It isn't saying that they expect to get it although I really believe the results will support a EUA, but the PR was such that it invites speculation.
NP has said 5 to 10 billion in sales in first year, how realistic do you think that is? It seems as if Covid19 has slowed in US, but what about other countries and other strains? If given EUA, and sales go up, I'm sure CYDY will have to employ many more people, just to deal with the logistics of the situation. But a valuation of $20B doesn't seem to reflect sales of $5B much less $10. Also as you mentioned the other indications I believe would be more, as there is NASH and cancer as well as HIV.
You say $10 by end of March if EUA. What do you think is sp if MHRA and Canada also give EUA?
Will EUA help with other indications? If leronlimab is given EUA then aporoval what does that mean for HIV and cancer approval timeline?
I believe CYDY will get EUA from all agencies mentioned in PR. What are expacations for timeline of uplist, full approval? What are the chances of extreme short attack if EUA is granted and sp go down?
It's going great. I'm just nervous that Jan revenues haven't been released yet. I hope they are not lower than Dec cause I think this is one thing that would put a big anchor on our accent past $2.00.
Uplist and EUA together would be awesome! If that were to happen, and MHRA and Health Canada were all to give it at the same time, talk about a rocket ship, the shorts not only would be burned, but obliterated. What a thought!
Is it normal to have discussions before data release? The CD10 trial showed results with NEWS2 scores, but CYDY was told not to apply for EUA. Why now after unblinding of CD12 are there discussions going on? Other companies have had results released from trials, then have to apply for EUA, what's different that CYDY is talking with different countries? Is it possible results are OK but not great and CYDY is seeing who will approve? From past EUA approvals we've see, it only has to show potential benefit, so I believe leronlimab passes this test. I am hopeful they all give a blanket approval as this is needed worldwide to combat covid19.
Do CD12 results come this week? Many speculations have been put forth about timing, but a month after NP said hopefully next week, I am hopeful very soon. Getting difficult for a non medical person to see any more reason for delay, although I believe results will be worthy of EUA. Does anybody think NP will partner up and that's possible reason?
I believe this to be true, and it may be the reason the FDA will try to drag their feet giving a EUA. I hope it doesn't happen for the sake of the lives that could be saved with expidited EUA, but if it is granted, CYDY becomes BIG PHARMA overnight, and all the other's recoginise this. Then the FDA may feel pressure from those writing their paychecks to keep a tight rein on leronlimab, such as saying S\C only. Who knows, but in my opinion when doctors start using this around the world, I think NP's prediction of 100+ sp is possibile.
I would like to see Jan revenue.