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Well, we can’t exclude the FDA!! You yourself said earlier today that the FDA would not approve a LL, not because it was effective, but because the FDA didn’t like or approve of Nader!! So if FDA is capable of making decisions based on stupid crap like that, It would look very suspicious if all of a sudden the drug would be approved because some else was in charge(ie.. the 13D group)!!! Don’t get me wrong, I think the FDA is fully capable of denying or approving a drug based on your criteria (Nader)!! Question is, will they feel exposed if approval is granted just because someone else is at the helm (13D group). The FDA would definitely be exposed!!!
Not shooting the messenger!! I am agreeing with the messenger!!! That the FDA would not approve a drug because they didn’t approve of CEO!!! I agree!
Man, so unbelievable but believable.... FDA not approving a drug because they don’t “like” or “approve” of a CEO??? Just think, if they are willing to deny a drug for those petty reasons mentioned above, what they might do for their buddies at BP!! What if the FDA doesn’t approve LL with the 13D group because it might expose them as approving or denying drugs based on your point in your post? I mean if they are willing to deny it for the stupid reason you gave (the FDA doesn’t approve of CEO) couldn’t they deny it with 13D group just so they don’t “look” like they are approving or denying drugs for such insane reasons?
Yep, just like Humira (a monoclonal antibody) that treats psoriasis, arthritis and crohn’s disease.... pretty amazing stuff. Just by blocking TNF!! Wonder how much money has been made on that drug. I am sure their were people saying similar things as your post during the development of Humira. Well, it works on “all” those indications. Plus, Humira was approved WITH SAE’s and require blood monitoring every 6 months for TB other issues. So far no SAE’s for LL.
Hey man, your the guy that’s making the point the FDA will disapprove a drug because they were “harassed “ by share holders. Your words!! Just think if they would disapprove a drug because they were harassed and are upset how about disapproving a drug for money or a sweet job once they leave the FDA. Your point is spot on....
I thought we were talking about your statement about the FDA not approving a drug because they were “harassed” by share holders. Nice try....
I believe what you are saying!! The FDA didn’t approve a life saving drug because they were harassed......totally believable!! What a bunch of 5th graders. Really good point on how the FDA works. Here is a drug that could really make a difference and save lives and the FDA says “No Way” you made me mad from harassing us so people must die!! Yep sounds like something they would do..,.
Going out of the country was a bold move. I think going out of the country lead to the letter from FDA. They felt threatened. Still can’t get over that opening line “Due to significant public interest” we are writing a letter that will hopefully bury your company. Lots of people were saying “don’t make the FDA mad” including Nader. If that statement is true, it would imply the FDA wouldn’t approve a “LIFE SAVING” drug because you made them mad?? Think about that one for a second!! I think they didn’t like the fact that Nader was going around them and could possibly make the FDA look bad so out of nowhere WHAMMO they put out a hit piece.The letter also gIves themselves some wiggle room if drug gets approved over seas. Some will call this post a talking point, but the data was already out there and yes CYDY looked at it from 7 and 14 weeks which was not the trial protocol but it did show marked improvement over SOC (was that out of bounds?) I would think that during a pandemic numbers like that would get the FDA EXCITED!! Huge improvement over 14 days!! So why did the FDA feel a letter (hit piece) was necessary? Oh yea “significant public interest”. Yea right
Yeah, how gullible were they as a pre revenue company???? Hmmmmmmm..
A lot less riskier investment now that are not a pre revenue company. Rut roe....
Isn’t it amazing the whole time we have been talking about CYDY they were pre-revenue. Now they are not....rut roe as the scooby would say!!!!
It is humorous....
At some point in the movie he will have to run at full speed.... Maybe a scene where the FDA is trying to get the patent for LL!! Or his significant other is dying and he has 4 shots (once a week) for his significant smoking beautiful co-star.....
Except move it from 97 cents to 5$ in 2020. Oops....
Out of significant “public interest” I am writing this post saying the FDA is corrupt.....
I think it says more about the FDA than it does about angry emails from investors. So with your reasoning the FDA is pissed about angry emails so they try to squash a possible lifesaving drug by being vindictive?? FDA- Send me negative emails, I’ll show you whose boss!! Just the fact that you make that point is frightening, but dare I say believable!!
Love it! Nice work!!
Holy smokes Grip, glad your Dad is ok and has a full recovery!! The point I am trying to make is if India gives EUA and real results are proven for LL. FDA and the DSMC are in a box and they know it!! I think they thought if US FDA wouldn’t approve LL for EUA, no other country would. Well if other countries do approve EUA, Uh Oh!! Send a letter for the “public interest”. Just my opinion. Don’t know for a fact. Just experience guided by intelligence when it comes to the FEDS and how they cover their asses...how is the putting stroke?
So your in the middle of a pandemic. Your in the middle of a trial the first two shots have shown great results. The people who are doing the trial ASK for two more shots because we have seen great results!! FDA (DSMC, by the way can “STOP”, “CONTINUE” or “ALTER” a trial) says nope you only have two shots for your trial that’s it. Do another trial if you want four. This letter that was sent out due to the “public interest” really you believe that.....They received to many emails, really? A lot of phone calls? The only thing that has changed since the results were made public is India and the Philippines. If 1000’s of coved 19 patient are treated with LL and the results are great. It would not look good for the FDA (DSMC). I don’t think the FDA thought Nader could get other countries to approve. This looks very possible now, and the FDA needs plausible deniability. Send out a letter due to the public interest. Give me a break....CYA
What am I denialing......200,000 vials sent. Letter from FDA due to “PUBLIC INTEREST” total BS......
I feel a total reversal is coming from FDA. This letter tells me they are nervous. Expect a reach out from FDA. This letter is a “”Oh Crap” letter. They are worried what results may occur in India and Philippines. Would not be surprised after Philippines and India start jabbing, a quick approval for EUA. If you don’t believe today is a CYA letter from FDA, I have some awesome swampland in Florida I would like to sell you. This letter tells me they are worried about results in these countries which would indicate a buy signal. Not as smart as you Doc, just my guess work....this FDA letter reeks!!
It sure does make today’s letter from the FDA look very timely doesn’t it. India and Philippines starts jabbing people. The results are fantastic. The news starts spreading around the world. UH OH!! says the FDA so they send a letter out today because of such “public interest”. BS!! This letter is a letter they will bring up at the hearing when Rand ask, why are other countries using this medication and having great results from a company in the USA and we are not!! FDA response,well we never said it wouldn’t work! We needed more data and even said we would help with a new trail. Not an easy question to field if your Janet or Fauci. So out of nowhere you send this letter out due to “public interest”, no way. They know if this drug is successful in Philippines and India there will be some explaining to do and the letter today is extra help for them. Why today? I think they know this will be standard of care at some point and are scared to death of how they will have to answer for the fact they did not approve LL. iMO
Check the Wall Sockets!!
Harish knows his stuff!!! Very believable!!! Great job...
Recknor rocks!!!!
Gloss over?
Revenue company by next week......
Nice post....
Holy smokes!!!! Pain and irritation at injection site. Better let them die then....
C-20, couldn’t have put it any better.... the response to your valid observations proves it.
I have seen less movement in a nomad.....over under for 6 months. You think he ever signs a lease longer than 6 months?
Just a little over a year and a half ago you could have bought 3,000,000 shares for $840,000 (.28 cents per share). Just a little over 1 and a half years ago your $840,000 of CYDY would be worth 9,180,000 as of today. Sure cherry picking when you sold is just as important as cherry picking when you bought. Yea, yea, yea if he sold late June of last year he would have made over 29,000,000 on a 840,000$ investment in just over 6 months. Not bad for an OTC Bio-tech investment. With what’s happening around the world I am more confident now than back in June of last year. Why you might ask? Philippines. When the revenue starts coming in (and it will) and the world sees LL saving lives this thing will rocket. Other countries will hop on board (UK,Canada and Brazil). The FDA will have no other choice but to approve. LL will be used for other indications (the biggies HIV and cancer).Last years stock price of 10$ will have looked like a steal. If mercurio still has his 3,000,000 shares he will have to employ a driver to chauffeur him to big fund raisers, because a lot of people will want a piece of of his immense wealth....
Yea, a whopping 4 days old with a weekend thrown in....
Someone totally disagrees. They just forked over 25,000,000 bucks. What do they know that you don’t?
So if the DSMC says the drug is not working and “recommends” stopping the trial at mid point, Cytodyn could say nope it’s our trial we set it up and we are going to keep going even though you “recommend” we stop. Similarly, if the DSMC “recommended” you “modify” your trial (the very people who are instrumental in approval of your drug) you would say nope, no modifications we are going to do it our way. How about the last option, DSMC says don’t make any changes, you think the company would say forget those guys let’s add two more shots for next 14 days. Doesn’t fly, the DSMC DOES run the trial wether you believe it or not. For the DSMC to see the results after 14 days and not modify trial by adding 2 more shots for let’s say half of the trial group was just stupid. Very, very puzzling....
Right on...
Laughing...
Who needed that clarified?? Duh
Would have been nice if the powers that be would have done something after the awesome results after 14 days (decreased mortality of 82% with a P-value of 0.0233 of critically ill coved-19 patients). Remdisiver shorten stay in hospital by a few days, APPROVE for an EUA because we are in the middle of a pandemic!! People critically ill with a decrease of MORTALITY OF 82% after 14 days with Leronlimab, nah we need to see more data... I don’t see how people could actually work at the FDA or DSMC...
Well said...