ilovetech
38分前
As for the SP, IMHO, I can see LP having a plan A and a plan B, with either executable in short order. We can pretty much assume that the wolfpack is prepared to resort to their standard playbook. Does she bait the Wolfpack with less meat on the bone, to see what the pack is willing to throw at the announcement, pre-market, at opening, etc.? Let's consider plan A consisting of positive achievement announcements in succession, spaced and timed, with the trading action in mind. Let's suppose for some reason that the MM's have a way, you know, whatever their illicit methods are to prevent the SP from running up.
LP would have plan B, or the mother of all bazooka's to deploy. It could be any number of options really right? She could announce:
- Direct trial official start date
- Signed Partnership(s)
- Eden Rollout
- C rooms ready
- Merger announcement i.e. with Revimmune and or with an additional synergistic entity. LP is a monster in this area. I wouldn't want to speculate.
- A new CUSP registration number under submission.
- Granular plans of a move to a different exchange, and what the specific steps will look like.
- Miscellaneous insert here___'''
She had a front row seat that infamous May 22 day which will go down in infamy. She's had a lot of time to assemble her strategy. Your most prized bullet(s) is, are, best fired upon a major catalyst, like your "FIRST OFFICIAL APPROVAL." Not before. It's not basketball with nonstop points scored over two hours. She's waited a LIFETIME for this moment. It's beyond stupid shorts spoofing. She has a soup to nuts, "turn-key" business she can embellish any which way her heart desires. Let's go!
skitahoe
1時間前
Smitty, all I'm saying it that NWBO has all sort of options. There is no set way that they must go forward.
I believe that if a hostile takeover were attempted they'd have to tell shareholders what was offered, and their intention to reject it. Such a move would be foolish as the share price would almost certainly rise to near the offer price and necessitate a higher price if the offeror were serious. I don't believe it will happen, companies don't like spurring on a bidding war, so they'll negotiate until something acceptable is found, but that won't happen at anything near todays stock prices.
Gary
skitahoe
2時間前
I'm fine with or without a BP partner, I just hope that if Toucan takes a far great position to fund the company it's at a substantially higher share price.
Once UK approval is in, EDEN approval is in, new trials have begun, and filings for approvals with other regulators are in place I think our share price will be approaching double digits, if not already in double digits. If Toucan is bringing in funds at that point, I'm fine with it.
I'm not certain that BP's won't be bringing in substantial funds to run trials with their products combined with the DCVax's. If that's the case, NWBO will be bringing in substantial money and giving up no equity for it.
I believe that LP has done an amazing job to reach this point and she has the knowledge and experience to keep this going till we're among the biggest of the biotechs.
I don't believe that LP needs billions, or even hundreds of millions to grow the company. I believe that vaccine production, distribution, and perhaps even sales will be done by CDMO's and others who will profit nicely from what they do, but may pay the company for the privilege of doing so.
I don't believe the company will sell the EDEN to anyone. Others may pay to lease them, or the company may provide them, the point is, such agreements can be structured in numerous ways. If another company pays more for the rights, they'll make more for each batch of the vaccine they deliver. It will be up to all of the companies working with NWBO to negotiate the terms of their specific agreements. I really can't say if this will be just one or two companies, or if LP will have numerous companies located all over the world licensed to utilize the EDEN system to make the vaccines for certain geographic areas covered by their license.
In the past I've voiced the opinion that Advent and CRL could handle this entire effort if they wished, but that's certainly not the only choice. No one knows, CRL might have no position at all, we'll only know when something official is announced.
Gary
skitahoe
2時間前
If by the time of the Annual Meeting we have the UK approval and perhap a great deal of additional news resulting in a share price well over $1 I believe that shareholder will have no qualms about increasing the authorized shares, the only question is, how high.
Frankly nearly all the longs I know would eventually welcome one, or more BP's taking an equity position in NWBO as part of a partnership with them. Most believe that LP would take them in at a market cap of $20 billion, or more.
That market cap would represent say about a $10+ share price if shares outstanding are approaching 2 billion, and that many shares may be necessary.
Why? Because if a BP is taking say a 20% ownership in NWBO, they're either buying all those shares from the company, or the company is providing say 50% of the shares to generate a lot of equity being available, and shareholders are tindering the remaining shares. Either way, substantial shares are required to permit a partner to have an equity position. If the partner was paying $12 a share, and say 1.5 billion shares were outstanding at the time, over 300 million shares would be required to give them a 20% interest.
If the company issued all new shares to meet the demands, they'd receive hundreds of millions to operate with, but of course the O/S would grow by over 300 million shares.
Of course we don't necessarily have to commit to the shares needed for a BP partnership now, but at some point sufficient shares will be needed to do it.
I have no qualms about giving management the shares needed for a future partnership once we're looking at a share price in dollars, or not, but if we are to take in a BP partner, and bring in a great deal of working funds by doing so, a lot of shares will be needed to do so.
Gary
Lykiri
3時間前
This new medicine had an extremely long duration from 1st CHM meeting to approval – 378 days, which is the second longest in my dataset (just beating out mRESVIA (371), which was approved last week, and just behind Sugemalimab (398), the longest in the set).
tunnelvisionofplenty,
I think it's more like 224 days between the first CHMP meeting and the approval today.
SUMMARY OF THE COMMISSION ON HUMAN MEDICINES MEETING HELD ON
THURSDAY 25TH JULY and FRIDAY 26TH JULY 2024
The Commission considered and advised on medicines used with another cancer medicine to
treat adults with lung cancer called non-small cell lung cancer when the cancer has spread to
other parts of the body and has gone through certain gene changes.
https://app.box.com/s/jv487awvqzzsrdql0o34h9gg350ceyd4/file/1722468014372
The Medicines and Healthcare products Regulatory Agency (MHRA) has today, 6 March 2025, approved lazertinib (brand name Lazcluze) for adults with non-small cell lung cancer that has spread to other parts of the body and has undergone specific changes in a gene called epidermal growth factor receptor (EGFR). It is to be used in combination with an approved cancer medicine called amivantamab.
https://www.gov.uk/government/news/lazertinib-approved-for-use-in-combination-with-amivantamab-for-the-treatment-of-adults-with-non-small-cell-lung-cancer?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=38e7cbd1-9503-4735-8318-3d76dbcde455&utm_content=immediately
NOTE: SUMMARY OF THE COMMISSION ON HUMAN MEDICINES MEETING HELD ON
THURSDAY 21ST AND FRIDAY 22ND NOVEMBER 2024 published today.
https://app.box.com/s/jv487awvqzzsrdql0o34h9gg350ceyd4/file/1795506843637
ilovetech
3時間前
Besides, it was very poor optics from the Defense. A hail mary move of desperation, dumb enough to believe, that by some remote chance, Judge Woods could be snookered by a graph in need of further clarification. As a layman, it didn't take me more than one pass of Posner's amended filings to understand, that the bar at this stage is naturally much lower, otherwise, Defense could game the court indefinitely. With the idea being, "if you have nothing to hide, and you've done nothing wrong, then with discovery, you have the opportunity to prove it."
skitahoe
4時間前
Doc, I believe that we're far from knowing all the benefits of DCVax-Direct. Remember, at least at first Direct is intended for patients with inoperable cancers, which I would gather to be more advanced cancers. By that time the BP's will have already sold all sorts of products for their treatment, unless DCVax-L has eliminated the need for at least certain products before then.
I believe that we all believe in time that DCVax-Direct could have tremendous benefits if employed before surgery. I would hope that given well before surgery it migrates to the mets, which can't be found, seen, or removed during the surgery. It's the mets that often have the cancers reoccur many years after what was believed to be a completely successful treatment years before as the cancers return in different organs.
Hopefully making the vaccine from the tumor after surgery will also go after the mets, but I would hope that Direct could play a big part if used prior to the surgery.
I still suspect that in time one or more of the BP's will want to partner, or acquire NWBO. I would hope it's partnerships as that will give them greater equity as the company grows, but still permit our investment to grow dramatically. If we're bought out, while very profitable to us, it immediately ends our growth, and creates a tax consequence, unless we can choose to take stock in the acquiring company.
Gary
skitahoe
5時間前
Perhaps I'm crazy, but I really believe that a BP who's making a profit on a product treating GBM, but where 95% die in 5 years, wouldn't be better off by 50% or more living to 5 years and beyond who'll be using other of their products the rest of their lives. I believe that they have the potential to sell far more products to these people over perhaps an average of 10 to 20 years they may continue to live than in selling a high priced med for a matter of months before they die.
I'll grant you that oncological drugs are generally more expensive than many of their other products, but without even realizing it we purchase all sorts of products made by BP's routinely. No where near everything made by most BP's require prescriptions, your toothpaste, mouthwash, moisture creams, etc may all come from BP's or contain material provided by them.
I don't doubt that it's true, some BP's don't want DCVax-L to succeed, but I believe it's a very short sided approach. DCVax-L isn't the be-all, end-all product, it still requires other products to achieve cures. Some BP products will continue to be needed, but instead of being needed for a matter of months, when over 50% have died, they'll be needed for years with 50% or more still living. I don't know that it's known exactly which products will be obsoleted, and which will be required in greater quantities because people are living, but I suspect that overall, the BP's will be selling more, not less. Granted, obsoleted products won't be sold, but others will be sold potentially for years.
Gary