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Where is the announcement about a reverse split. I'm not seeing anything. Is this real or is someone short and spreading rumors? Thanks.
Excellent! Hmm, government contracts? This is getting interesting. :)
Koichi also acquiring PSGI, another moody corporate revival. So WBBA is the franchise operation in charge of opening restaurants in Asia, DRFS is making the product. Wonder what PSGI is going to be?
Nice bb! Thanks for posting it. I already have WBBA and DRFS. This is going to be huge!
Great update today about taking over Mama Foods! Smart move. Koichi Ishizuka obviously has a master plan and is executing it! I've been invested since Ambient. Moody plays are the best. $DRFS
$COFE New Moody/DeNunzio custodianship granted today. :)
Sweet! Thanks bb!
You are correct Dodgeball. Findings of fact should be up to a jury. Findings of law to the judge. Leave to Amend is usually granted as well. The judge overstepped here and it is a true head scratcher.
For example, here are some typical rules of civil procedure:› PLEADINGS AND MOTIONS › Amended and Supplemental Pleadings
Rule 15. Amended and Supplemental Pleadings
(a) Amendments Before Trial.
(1) Amending as a Matter of Course. A party may amend its pleading once as a matter of course within:
(A) 21 days after serving it, or
(B) if the pleading is one to which a responsive pleading is required, 21 days after service of a responsive pleading or 21 days after service of a motion under Rule 12(b), (e), or (f), whichever is earlier.
(2) Other Amendments. In all other cases, a party may amend its pleading only with the opposing party's written consent or the court's leave. The court should freely give leave when justice so requires.
(3) Time to Respond. Unless the court orders otherwise, any required response to an amended pleading must be made within the time remaining to respond to the original pleading or within 14 days after service of the amended pleading, whichever is later.
I agree. The NeuroRX CEO posting on a yahoo message board? That just reeks of desperation. Either he's unhinged, or perhaps it was someone pretending to be him? Not sure, but this is very, very irregular. Why am I still invested in RLFTF? Because I believe that Javitt/NeuroRX has very little to stand on legally with all these ridiculous claims.
At this point, Javitt is appearing delusional, but I believe it's all a bunch of hot air to wrangle a higher profit percentage out of Relief, and to try and encourage RLFTF shareholders to come over to NRXP.
In my opinion, Ram has done a good job setting up Relief to move forward independent of Neuro. I am holding my investment here.
That's great news PennyWorld. Sounds like NRXP is going to have to produce the financial records that were requested by RLFTF. Assuming the expenses were legitimate, RLFTF can opt to pay some or part of them which may resolve the issues. However, NRXP is likely going to try and mediate their way to a higher shared percentage of profits. All in all, a much better resolution than years of costly litigation.
No, that is NOT a fact and you have no way of quantifying it. Ridiculous. For a typical election, only about 50% even bother voting. With all the confusion surrounding this "contested" election and the last minute proxies, it's no wonder turnout was low.
I voted "for" the cydy slate as well.
The bottom line is Amarex had two years to finish the BLA, and didn't even correct the formatting issues, or the problems the FDA raised in their earlier letter. CRO's have control over what data the company can see and what they can't, so to claim that CYDY should have known about these issues is incorrect. They have to rely on the CRO. For whatever reason, Amarex failed to perform. Their failures have damaged Cytodyn and the shareholders.
I can appreciate Pourhassen's frustration that the BLA wasn't completed in the timeframe promised. Cytodyn was allowed to submit the BLA in sections, so he may not have known the condition of the dataset. I don't fault him for trying to protect the share price and get it going. I am happy that Recknor was hired and they are moving forward with more hands on deck to oversee the process.
The 13D proxy materials were still up and available on the online brokerages, even after their claims were rejected by the courts. By the time the court case was concluded and CYDY proxies were available, there wasn't much time to vote. I didn't receive anything via regular mail either. I'm not surprised that there was low participation.
An interesting Post from Respert:
It's going to take a lot more than reddit posts and a couple singled out emails to sway me from the overwhelming scientific evidence and potential of Leronlimab.
As in anything that gets discussed these days, you can find a treasure trove of relevant information just hanging out on the interwebs waiting for you to swing by for a look. For instance, let's take a break from about out-of-context words, or Amarex sucking at a level Hoover could never achieve, and look around at a couple world wide websites.
Here's one:
https://www.bio.org/sites/default/files/legac...202016.pdf
This is a study of all NDA (new drug applications) and BLA (biologics license applications) over a ten year period to see what the chances of approval looked like. There's a handy table that shows the success rate of these drug candidates broken down by disease state and the percentage that were successful on the first, second, or (as mentioned in the presentation it can be up to 4 times) eventual approval, including the time it takes from submission to approval on average. Spoiler Alert! It isn't that great. The average time from submission to approval is 1.6 years. And the first attempt success rate for companies with an autoimmune drug candidate are 63% while the overall (all disease) average is only 61%.
The good news is that the eventual success rate of companies that have gotten to the BLA or NDA stage is actually a good bit higher at 86% across all disease states.
A couple other relevant notes from the article/presentation:
" During the time frame of this study (2006-2015), programs entering clinical development in Phase I were found to have only a one in ten (9.6%) chance of advancing all the way to FDA approval."
"The higher success rates for trials run with biomarker-selected patients suggests that the broader industry is already on the right path. For example, Phase III transition success rates in programs utilizing selection biomarkers in the last decade were 76.5% (n=132) compared to only 55.0% (n=1,254) for non-biomarker trials."
"These rates are the result of eventual success, not success on first review, meaning some programs may have as many as four Complete Response Letters (CRLs) and attempts at approval."
Oh hey! Here's another one from 1992 and I'm guessing it's gotten harder, not easier:
https://www.cato.org/sites/cato.org/files/ser...indication.
"If the drug still appears to be promising, the firm submits the results of the trials to the FDA in the form of a new drug application. Applications are typically 100,000 pages long . Finally, the FDA will approve the drug as a treatment for a specific indication."
"Of the 80 to 250 new drug applications firms file annually, the FDA approves only 20 to 60. Many of those represent reformulations of existing products. In all, firms will market about one out of a hundred of the products for which they have developed patents." (That's a hit rate of 20-25% way back in 1992. Clearly it has never been all that easy to get a drug approved)
OK, let's do one more:
BLA Submission Reform is on its way.
https://tinyurl.com/45prd4rs
So maybe give this small team that's doing their best a little bit of a break, eh? Over the course of 7 years, hundreds of thousands of pages of compiled data, a global pandemic, the FDA changing the HIV dose at the last minute, BP trying to steal the company's IP, Amarex being inept, "hidden" forces attacking the company to drive the share price down, and a variety of other issues, maybe getting butt hurt about a single email (presented without the rest of the conversation) is more than a little ridiculous.
What that RTF letter makes clear is that Amarex was not doing their job, and made little progress in the two years they were supposedly "working on the BLA." I can understand giving them the opportunity to fix it after so many years and so much money invested, however they were unable or unwilling to perform. It's no wonder Cytodyn stopped paying them and ended up filing suit.
BLA filings are very complicated, especially with multiple doses that require justification. This level of detail is not something that a CEO normally manages. I'm very glad Recknor is now on the team and getting it sorted out. I expect major headwinds before first approval.
Thanks for all the info Changes. VIP is an amazing peptide. I think it's going to do a lot more than we realize!
Thanks for all that great info Changes IV. That is all very good news for RLFTF shareholders.
Yes PennyWorld, I wonder that too. Does anyone know how many shares Javitt and family have and what their majority/minority stake is in Neuro? How much control do they have? Is GEM the majority stakeholder in which case they can vote him out?
It's really in GEM's best interest to settle this right away, but even if Javitt agrees to comply with the agreement, is he a reliable and trustworthy leader moving forward? Or is he just bluffing and blustering trying to get more $$ and will knock it off once he realizes he's not getting anything more out of the Swiss?
Yes, NeuroRX has 30 days to answer the complaint, but per SEC regulations they have to notify shareholders of the lawsuit within four days. They can't just withhold the information, it's material to shareholders.
RE: the lawsuit against Amarex. Yes, lawsuits generally take a long time, however Cytodyn is asking for injunctive relief. Injunctive relief is used when monetary damages aren't enough, when you want the court to order someone to do something, or stop doing something, LOL, as soon as possible. In this case, Cytodyn is basically asking the court to order Amarex to turn over the data/passcodes right away. Dr. Recknor's declaration made it clear that time is of the essence, and discussed numerous reasons why they need access to patient data asap or they will be irreparably harmed. This type of court order is handled typically within a few days or weeks, while the rest of the case for monetary damages continues on through discovery and trial.
Great update! Thanks for posting it.
Glad I never saw that photo, LOL. I would probably make me nauseous.
I'm very happy Ram and RLFTF are moving forward overseas.
Vanilla, I confess, I have been very annoyed by your constant negative posts. I thought you were a basher or fear mongering. Your choice to "shout it from the rooftops" over and over again using tons of capitalization, made me disregard you and your message. But, truth be told, you were right all along. You obviously have a very finely tuned BS meter. LOL And you could tell something wasn't right.
Javitt is a snake and he has damaged the drug and this company. He has no legs to stand on and will lose this fight in court. If he's smart, he will realize his intimidation tactics aren't working and get on board immediately and start complying with the collaboration agreement.
I expect that financier GEM will put a stop to his power grab immediately. They are heavily invested in both companies and would be damaged if they don't get their collective act together. This is beyond the pale.
Wow, is right! Dr. Javitt is one slimy operator. I am blown away by all his schemes to defraud Relief!
Yes, I agree. I am happy to see Relief asserting themselves here. Neuro is in breach of their contract. Relief gave them ample time to resolve it. It’s time to take action.
Good, it's about time. I've been waiting for this. Dr. Javitt has not acted in good faith here. He's got a lot of nerve stealing the drug he was supposed to promote. Is he so arrogant that he thinks he can get away with it?
Actually, no the data formatting is not Cytodyn's job, that's on Amarex. So glad we have changed CRO's now.
And how many of those 71 members are still part of the 13D? Aren't the only ones left the people that are invested in IncellDX? You just made my point, Closet, thank you.
Face it, you all got screwed by Patterson, and you really need to start placing the blame where it should be, with Patterson, instead of constantly bashing Nader. You bet on the wrong horse, unfortunately. Your campaign to drag CYDY down in an attempt to further the 13D is a failure. If you buy CYDY now, while it's still low, you will hopefully recover your losses from your investment in IncellDX. Come out of the closet and be a part of the solution, not the problem.
If you read Dr. Recknor's full declaration for the motion you will see that they are referencing formatting issues, incomplete headers and the like, not data problems. Basically, Amarex wasn't doing their job to format the data and submit it correctly, which explains A LOT of the issues with the BLA filings.
I find it very compelling that quite a few of the 13D group are investors in IncellDX. In fact, many invested via convertible notes in the fall of 2020, right when Patterson was contemplating a buyout by CYDY. Looks like those investors got hoodwinked, cause they gave their money to Patterson, and got nothing in return. Patterson blew it, ruined his relationship with Cytodyn by trying to patent their intellectual property and by asking a ridiculous amount for his company. He got greedy and thought he knew better. He was wrong.
Thanks Jay8ird. VERY good news. Can't buy it yet at etrade but I'll keep checking!
Thanks Harr. Is this one SOLU?
Thank you for your posts PennyWorld. You always share great information. I am interested in how the ADR will effect the OTC shareholders too. Looking forward to hearing more detail about it.
Would love to buy in, but etrade won't allow an opening position in a "Pink No information." Hoping the record gets updated soon.
It does feel like it's taking a long time to get underway, but assuming an early September start, that's only about 30 days from approval to first injection. Logically, I know that's a pretty reasonable timeframe. Still, it's hard to wait considering all the people in need. I haven't seen any government agency in any country acting with the speed or urgency I would expect during a pandemic.
What I do know is while we wait, there is work going on behind the scenes. Frequent updates to the clinical trial record indicate more and more hospitals are signing up to be part of the trial. And the academic research organization in charge of the trials, Albert Einstein Israelite Hospital, is considered one of the top hospitals in Brazil. In my opinion, this trial will be life-changing, not only for the lucky patients that receive Leronlimab, but for the company and it's shareholders as well.
New trial sites added to Brazil trial. Over 30 different locations, they are really ramping up. Once the trials start, it should fill very quickly.
A motion to dismiss a complaint is typically based on procedural issues. For example, if the Plaintiff failed to state a claim, filed in the wrong jurisdiction, or didn't have standing to sue. Typically, the judge will give the Plaintiff the opportunity to amend the complaint if the issues can be cured.
At the outset of litigation, Complaints are not supposed to be judged based on "questions of fact." Whether or not combustion occurred is a question of fact. Factual issues are supposed to be left up to the jury to decide, or, if it's not a jury trial, it would be up to the judge to decide, but only after discovery has taken place and both sides have fully presented their case. That hasn't happened yet, and one exhibit attached to a complaint does not a case make.
All this motion is determining is whether the complaint is sufficient procedurally to move forward. The parties will still have to prove combustion and infringement.
I expect that PM's motion to dismiss will be denied. All in my opinion.
Beautiful! Can’t wait for Monday. GYGC
Great opportunity to load up. Added more this morning.