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I don’t have a negative outlook on management as you do, but I don’t think I’ve been invested as long as you. I do agree though, missing this deadline would be a disaster and would completely change my opinion of management.
I think the PR was worded carefully regarding the date approximation. However, I don’t believe there’s any chance they miss the 45 day window.
Very possible. I’m just looking for the MAA application to be submitted for now. UK approval would be huge for them. We can worry about other countries later. I personally believe we won’t see a BLA filed until after UK approval.
I don’t recall LP saying they were going to file with all 4 RAs this year. From what I remember, LP said she would file as soon as they can. She also said they would be strategic about filing. I agree an update on other RA filings should be given. However, I don’t think LP ever represented it would be done this year.
Nice work!
Thanks. I think if we don’t get acceptance by 10/12, then they’ll PR submission. Possibly they just PR both.
The IND is for them to make the vaccine for research purposes. It is the same vaccine. This has been confirmed over and over. If this vaccine had been changed, there would either be a new IND or an amendment to the old IND. Can you provide that?
The listing for Keytruda is in the “other names” section, not in the actual study. Go look up a study for ibuprofen and check to see if every trademarked name is included in that section. The answer is it’s not.
Is submission to acceptance done within 14 days? I read something for medical devices that submission to acceptance was 5 days.
So Dr. Liau is mistaken. Dr. Prins, who stated NWBO has nothing to do with the trial, stated UCLA has “had our own IND for this vaccine”. So when he said “this vaccine” he really meant another vaccine? Both these doctors but you are right?
The trademarked term is DCVAX-L. The trademark name is not listed on studies. For example, why isn’t Keytruda listed on the study? Are you going to say Pembrolizumab and Keytruda are different? Or did you figure out that they don’t use the trademarked names on studies?
Nothing has to be stated anywhere. It’s not their study. It is UCLA’s study and LL confirmed it is the same product. Again, if UCLA is running a study, who would have knowledge of what product is being used? NWBO or UCLA?
Shouldn’t UCLA be confirming that because they’re the one using it? LL also confirmed it as well.
If this wasn’t NWBO, I think $6–$8 would be a fair value today. $10 will come. I would say FDA approval would almost guarantee $10+, but I think we will get there prior to approval.
Yes, I think we turn a corner soon. This will be the last month that we’ll be under a dollar. 4-5 years from now, those crazy valuations that have been floated around on here may not seem crazy anymore.
Anytime. With our diverse backgrounds, we can all contribute here.
I wasn’t referring to the technology. I was referring to the increase in survival and treatment price.
I believe we are at least 6 months away from a FDA application. I think we will see MAA approval and a partnership before the BLA is submitted. LP has mentioned being strategic in application submittals. FDA will probably be the last one.
Care to explain how Optune was approved?
Yes, but the judge probably had not reviewed the filing when the oral argument was scheduled.
Surprises don’t usually end well. If it was a valid point, it should have be brought up in the brief. If it wasn’t, the judge may then allow supplement briefing on the issue. It’s really used to clarify the issues in your motion.
Anything relevant can be argued. There will not be a later date for a response as both sides can argue their points. The judge can continue the arguments to another day if he/she wants to hear more. If an issue comes up that interests the judge, the judge can require supplement briefing on that issue.
It is highly likely the judge had not reviewed the moving papers when the oral argument request was granted. Judges typically do not review motions until they are fully briefed. In my experience, requests for oral argument are typically granted. That doesn’t mean every time, it means most of of the time. Any ruling on this motion is likely several months away. It will not be a simple denial or granted ruling but a written opinion explaining the ruling.
It doesn’t run counter to the argument. The fact is the brain is difficult to treat because of the blood-brain barrier. If they can treat GBM, then treating other cancers will be easier.
Whether or not a judge grants oral arguments has no bearing on the likelihood of success on a motion. This is neither good nor bad.
No they can’t. The only thing that is being decided is if the complaint as written is sufficient to constitute a cause of action. Essentially, they have to take everything NWBO pled as true for the purposes of this motion.
Our systems weren’t as capable as we thought. Negligence.
At the end of the day, I think they’ll be successful. However, this it’s not a slam dunk case by any stretch.
While that may be true, a violation of that regulation may not be enough to give someone a claim against a MM under 10b5. You would then have to prove the failure of the system, or not having a system, was due to scienter.
I think the big issue with WhatsApp is any communication used to discuss business would be a violation of the law. Doesn’t matter whether or not anything nefarious was occurring. Communications from SEC regulated businesses must be recorded. Those communications may be used to establish scienter. The real issue I see is if 3rd parties were spoofing through the defendants and it wasn’t the defendants themselves making the trades. That is what was stated in the moving papers. If that is the case, NWBO would have to prove the defendants had actual knowledge of what was occurring and why it was occurring. Negligence is not enough.
I don’t expect a ruling on this until early next year. Federal dockets usually are better than State courts. They usually set oral arguments 30-60 days out. Unlike state courts, the rulings will just come out whenever the Court issues them.
Oral arguments are typically done in one afternoon. In this case, maybe a full day max. It is not a delay tactic.
Further, unlike most traditional securities class actions involving misstatements and omissions, these claims are brought under 10b-5(a) and (c), a relatively uncharted area of the law.
https://www.lawdragon.com/lawyer-limelights/2023-06-07-laura-posner-is-leading-the-way-in-investor-protection
I think they will ultimately be successful. However, it won’t be a walk in the park. Thinking the jury is going to nail them is misguided. It’s now how the legal system works in my experience.
Don’t expect a settlement anytime soon. I don’t believe Defendants are afraid of discovery. If you read the papers, they believe their conduct doesn’t make them liable under the law. Trading records are electronic and will be turned over. The MTD will no be decided until early next year. Answers will need to be filed and discovery will begin which will take up most of 2024. I expect at some point after discovery is completed, summary judgment motions may be submitted. It is likely that trial would not be until late 2025 or 2026.
That’s more information than I received from the representative.
Just got a call from Fidelity asking if I wanted to participate in their share lending program. Ironically, I actually tried transferring my shares out of Fidelity last week because they weren’t very clear about whether or not they were lending out my shares since they were held in a margin account.
Morning shenanigans are over. Back to a slow ride up.
I know you’ve been here a long time. I think this year will truly make you a happy librarian.
Actually the average short position open is now 149.32 days old. That is roughly May 1 when the stock was trading at .50. That means the average short is down 100%. At that time, they were paying 1% a month to hold that position. They are now paying 10% a month. If the price and rate stay the same for a month, they are losing .10 a month. They are guaranteed a losing position after 5 months even if this stock went to zero. As the SP rises as we anticipate, and the lending rate remains this high, the shorts will be guaranteed a loss in as little 45-90 days.
He’s convinced himself he’s right. He was burned by CVM on a squeeze. He’ll get burned here as well except much worse. I don’t believe he added to his position today. There wasn’t many shares available to short. If he did, it could have only around 10k. It’s more likely he was part of the early morning takedown yesterday that was unsuccessful. He had a sleepless night and let it out his frustration this morning. He’ll give up and cover soon.
It would be nice to get pre-market news and open at $4. You’ll see the shorts run for the exits.
Got it. Very interested to see September’s numbers. Thanks.
Thanks!