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Are there any publicly traded warrants here??
Good question
Do you happen to know how many patents KULR currently holds?
New positions being taken leading into 1/6 update...
Cydy will turn heads soon
An EUA means FDA approval is imminent. The first monoclonal antibody with mortality benefits for Covid will DOMINATE the headlines. Which is why I want this uplisted before EUA granted. Massive buying would occur at this point. The BLA for HIV will be gasoline on the fire of a new company/drug that is on everyone’s radar.
I’m going with $20 end of January....lots of data coming this month.
I don’t disagree but I would say that timing has never been more important. All hands on deck for review and EUA submission. Lives literally on the line.
But, to your point don’t submit something that allows the FDA to delay approval because of some technicality
Appreciate your responses
Got it. That’s very helpful.
So, unblinding on the 12th. Company reviews and makes determination for EUA filing. If/when FDA reports back, company has 4 days to disclose.
I think NP has already stated they would release unblinded data on the 14th. If primary endpoint is met, it’s clear what the end result will be. Only way to catch shorts here is for NP to not publicly release unblinded data. Keeps people guessing on what the feedback would be for EUA request
Question for you...or anyone that wants to chime in
Does the company need to officially submit something for FDA approval following unblinding or does that happen in accordance with primary endpoints being met following completion of the phase 3 trial?
Does the data need to be unblinded before the FDA makes a determination?
I’m trying to understand how covertly this process can be to avoid tipping off investors of what the intentions of the FDA would be
If you aren’t entering now, or averaging down a bit, that’s on you. Longs, I applaud your continued resilience and faith in the technology. 2021 will be rewarding.
MS here as well...
I’ve been preaching to the pulmonary docs for months now...soon they’ll be on board. Standard supportive care measures have provided “expected” results.
This is funny...and accurate.
January will either provide 100% gains...or losses. Company will be fine either way
Ha!! Now that’s funny...
Dilution on the OTC is never good...ever....never. I get why the money is needed, but it’s worse than dealing with the mob.
Yes, most patients require long term placement for vent weaning. Your wife will beat the odds!! The sooner leronlimab is available to everyone the better. Survival and time off mechanical ventilation is a massive outcome. This can’t happen soon enough. Hope she continues to progress today..
From an investment standpoint, I don’t need them to breakthrough. I hope they do, believe me...
But, their tech makes them a buyout candidate or a target for a SPAC merger. Both of which provide life changing returns
Majic...the difference between why a company would conduct a share buyback versus a RS is huge. Essentially the company views its stock as extremely undervalued and would be investing in itself...the leverage and value a buyback creates if the pps rises is massive.
A RS doesn’t change anything but the float...it’s does nothing in terms of value added to the company. It’s just a math adjustment essentially
If there’s merit to the suit, the company will buy back massive amounts of shares to decrease float. The fact PM requested a delay is a good sign...
It’s too good of an opportunity to not jump in. It could completely change this company... and my bank account
Great time to jump back in here. It’s clear TMDI is going to make a big impact in the sector.
Wish I had .30s but I’ll take my entry point and watch this run in 2021.
If the company doesn’t follow up this offering with substantial (i.e. NOT fluff) news or impressive rev gains, they will be forced to R/S to get this pps to big board levels. I know Nasdaq is the objective, but this isn’t getting to $4+ organically this year. Raising funds is necessary, but it is a massive hurdle to churn through shares as investors dump and keep pps suppressed. It’ll be interesting to see what management does here and if they truly have the tech to overcome this
Exactly my point the other day. If you missed the opportunity to take some profits, you’ll be in this trading channel for awhile
What is the next catalyst here? Are we waiting for Jan 14th-ish for unblinding or something else?
I hate giving MMs 2+ weeks to push this down
Agree...it’s a company that is just starting the process. The tech is sold and market is exploding with opportunities for KULR
I’m long on this one...
I hate that there is time frame to hold. But that’s the way it is sometimes. Unfortunately there’s nothing from keeping this investor from dumping all these shares into the market which is going to require a whole bunch of buying to move this PPS back north. Alcohol dilution now is worth the opportunity to get in front of institutional investors though. I just wish I had taken gains yesterday as it was clear this was about to hit
That’s why the down titrations throughout the day are so very important. Conducting a sedation vacation from a high level of continuous sedation is going to fail every time. But, I’m not meaning to be critical of the staff managing her care...they maybe doing exactly what they should be doing. Each patient presents their own unique challenges. Hang in there....if her lung function/mechanics are improving, the weaning process will go quickly. She’ll be off mechanical ventilation soon...
I know..it’s incredibly hard from a family member’s perspective. Believe me.
Initiating things like precedex, routine haldol, oral long-acting benzodiazepines, will help minimize the use of shorter acting agents that interfere with the awakening and weaning trials. It’s difficult but I would make the nurses turn down sedation by 0.5mg/hr every 2-3 hours and use pushes for breakthrough to avoid just going right back up on continuous infusions. But...it’s tough...
Delirium is hard to recognize and often times harder to understand all the contributing factors. But, the trach will help...
100%
Often times the ability to wean off mechanical is retarded by the inability to allow for an adequate sedation holiday to facilitate a weaning trial. Often times it can be linked to poor management of sedation/pain medications required while the patient is intubated. But...that’s not going to help you at this point.
Acute delirium is often the rate limiting step and breathing trials after a trach are often more successful...especially if the patient is nearly the time frame for requiring the ET be removed/replaced with a better alternative.
Anyway, I’m confident your wife will turn the corner quickly at this point. Praying for continued improvement in her status
Well..ultimately that’s the question...at least from an investor standpoint. Commercialization and revs drive the pps. What is the plan here??
The EV sector is massive...and these companies know without the best safety technology, they are dead in the water
The EV sector is going to be hot in 2021. SPACs vying for mergers in the industry will be off the charts. Battery/storage solutions will be necessarily valued higher. I hope KULR has a plan for monetizing it’s tech. Commercialization is key and this company could explode onto the scene in 2021
I think it’s important to understand the rationale and impact of granting the open label extension
https://pubmed.ncbi.nlm.nih.gov/17253876/
I think there are ethical considerations on both sides, but I don’t think this is a situation where the FDA is trying to gather more post surveillance safety data on the therapeutic being evaluated. I’m convinced this is one of the few (although controversial) situations where the objective is to simply increase access to a therapy with clear/established mortality benefits. Giving access to new patients that don’t have 3 weeks to wait for EUA is compassionate and should be applauded
It’s an unfortunate display of what the public forums have devolved into. Instead of discussing the merits of a company or technology, it’s a cover/front for shorts/MMs to sew disinformation and manipulate sincere investors that may fall prey to tactics employed to steal money along the way. It’s truly an amazing example of the lowest form of investment strategies.
DD is paramount...so is taking gains along the way. Don’t fall in love with any OTC investment without learning how to make money along the way. You can wholeheartedly support a company, but MMs are powerful....don’t fall prey.
I’m still hopeful a Nasdaq uplisting comes in the next 1-2 weeks. Access to institutional investors will send this company through the roof as EUA/FDA approval becomes imminent
My concern is on the production side. I’m not sure if there’s a mechanism for the government to intervene but the available stock is a fraction of what the demand will be. Additionally, following FDA approval, the use for “off label” indications will be substantial. Not sure how third party reimbursement will approach this, but I have no doubt that this will be implemented at earlier stages in treatment algorithms. Trying to prevent progression to “severe” stages is key to any disease process. Reign in the inflammatory and immune dysregulation responsible for killing people.
Full disclosure...I do not have a position here but am considering
The share structure reported on some of the public forums may not be accurate, so if anyone would be willing to provide numbers for what the current float is, I’d appreciate it. Yahoo is reporting a float of just under 10M which is just a stupid number to report...
Agree...this will run up and traders will make bank when MMs bring it back down before unblinding. Good news is, time is short for their ability to do so. However, I can’t fault people for understanding how to effectively trade this and make money as it swings. I can’t...I’m here to hold until my target pps
All I know is I’m about 400 shares short of the target number I was after...I’ll be paying substantially more for those now.
I’m going to say $7 close EOD Monday and $10 EOW. There’s going to be some serious MM battles taking place during the next 2 weeks. Can’t wait....NP will keep up the pressure
Only thing that would make this better is a Monday morning uplisting announcement. They want this off the OTC ASAP if FDA approval granted
I can almost hear the shorts screaming now...
This
Seriously, I don’t know the answer to this but I’m curious how many drugs that are granted open label extensions are denied approval following completion/evaluation of their phase III
This is a way for the FDA to get patients access before formal approval. They know other countries are coming and NP has made it clear...first come first serve. It may be a bluff but it’s a powerful statement that the FDA needs to consider. They can’t slow walk this one
Holy shit man, did you just reference a 15 year old ethics review from Whales to make a point??
How many drugs that were granted open label extensions went on to be denied approval??
FDA allowing patients that met original CD12 inclusion criteria to be administered the active drug.
It’s a massive tell by the FDA. They wouldn’t allow the open label extension without confidence in the 1. Safety and 2. Outcome measures of CD12 study. It’s a massively important decision prior to unblinding and granting EUA prior to formal FDA approval
I suspect they feel a sense of pressure knowing other countries are going to grant approval. Inventory will be scarce..
Correct...