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You are correct.
Calendar days. Not business days. They would say Business days. Business daddy is a well understood but qualified and defined term and clarification. But you define it so that people coming to a document know you do not mean “calendar days”. This is a public website of a government agency. It is calendar days unless they say conspicuously, and define it as Business Days.
Our little friend has no idea of what she speaks and knows just enough to be a vandal.
It would not make serial processing impossible. And nothing I said suggested any specifically necessary or unnecessary context. Any such condition, if it existed, and it certainly could, would prevent serial processing. That’s a very flat world way of thinking about such things.
The whole point of and meaning ultimately of “automation” is serial processing and increasing efficiency. All kinds of processes that are complex and for which early simple minds had no conception of serial processing have been automated in such fashion and this will likely be as well. But at the moment, it is likely too complex and not necessary to get the initial scale that they need. However, I doubt very much the limitations people calculate here based on publicly available information and speculation is, in fact, a true upward limit. The whole point of putting processes inside of small, contained packages is, ultimately, serial processing. Initially it is simplest by machine. Ultimately, that won’t likely last as the upward limit because that is not real manufacturing technology, at its upward limit and the process innovation by itself suggests that they know that as well.
I expect someone told the first inventor of vacuum tubes that they might be able to fit more of them together somehow, the person might have said, that's impossible. Or after the first transistors were built, someone said, putting multiple transistors into a smaller space would be impossible, because x, y and z. But anyone with any sense of technology today knows where those inventions inevitably led. Today there is an obviousness about technologies and putting a process like this into a "cartridge" screams serial processing. Right now it is PER MACHINE. Whether the people move, or the cartridges move, ultimately, or the cartridges move sideways or up and down, it makes no difference. The invention obviates serial processing because that is where efficiency will be gained and that is how technologies like this evolve. End of story.
I believe they will be able to do serial processing in these units. The whole point of them is that they are doing the work inside of a sealed cartridge, hence the elimination of cleanrooms. When the product is idle, and the cells are digesting, discovering and processing antigens, there is no reason why the next cartridge cannot be in process, in the long-run. I think per unit they will ultimately do far more than 50 a year. It’s clearly what the technology was ultimately invented to achieve.
I think ultimately, the company will need to consider scaling that process beyond individual units as well, to automate beyond and to where the cost can be scaled waaaay down.
This is an encouraging article!
That page appears to 1) only list research that NBTS has funded and 2) Be primarily about their collaboration with Parker Institute for Cancer Immunotherapy, which is affiliated with Sloans Kettering… so of course they are going to talk about their own research, even if it has not been effective so far.
The date is irrelevant. That post was more relevant than 90% or more of the moats on the board on a daily basis. The truth is that those are the results of the trial, relevant to this vaccine and this company, being trumpeted by one of the top research center schools in the nation. UCLA and other schools have said similar things about the trial and DCVax-L, plus it is stated right there, it is not just a “breakthrough” for Brain Cancer, it is “non-toxic”!
It is more relevant than anything you have probably ever posted on this website or anywhere else about DCVax-L or NWBO.
It’s a contingent fee lawsuit… the lawyers they pay for are those getting them through the drug regulatory process, IP lawyers and any regular and normal costs for securities compliance and corporate necessities and compliance.
No, they will fill the board. Plus it honestly long arguments and inprobes the ability to rebut every argument. This is a waste of time as well though.
Have you fed the yahoo board or ever posted over there? 1) as long as anyone read it it was saturated with all basher posts. 2) if you posted anything positive, your post became the focus of basher posts. In the context where we dominate, they are also kept in check.
Otherwise, I do not see you posting a lot that would change the narrative. You seem to be making their case for them. Just a different angle. Like I said, some longs are swing traders.
First of all, you reply to a one sentence post implying I said all kinds of speculation, but that’s not there.
Second, the CDMO they needed did not exist. CRL saw it as unique as well and paid 1 billion for it and she was not the sole owner. The shorts were responsible for blowing that company up however. The result was that the company that had done all of their manufacturing during the clinical trial, and would enable easy approval, therefore, had its UK subsidiary and the CEO was in a position to save it and have it spun out for NWBO’s benefit.
So yeah, we were fortunate not to be required to hire CRL at great expense at this point and likely not in NWBO’s own factory, to develop commercialization plans.
You make it sound like a huge disadvantage, but the reality is entirely the opposite. But if she did not own it and it was the other scenario, and they were diluting now madly to raise funds for CRL, you’d be saying something much more negative. The reality is, nothing they do would ever be praised by you and your crowd. Your job is just to find anything you can EXPLOIT ti make your false light case.
Downrating doesn’t make the posts disappear. That would work in a social media site where ratings impact views. This is not that forum. It works on Twitter. Not here. Bulletin boards are a different animal. If you surrender bulletin boards, as with yahoo, and do not rebut the misinformation, the misinformation becomes the current view. They become useless wastelands.
Real rebutting, not name calling or just yelling at them, undermine’s their narratives and actually frequently makes them realize their latest attack isn’t working.
On Twitter, you ignore and block accounts with zero to two followers so that they do not attach to your own posts and free ride to your followers.
People need to understand how social media and different forums work.
Longs are Tricksy Hobbits huh?
Seriously, though, you sound like Gollum half the time.
What provable fact have you focused on today or in the last week?
Quit pretending Mr year after year as a short, that you’re concerned about investors… crock…
It’s so obvious.
Nonsense. The moment is the moment. It has nothing to do with Sojo. Shorts are working those 24-7 right now uhum.
Thanks Stonk. Something real with regard to the MAA application, rather than the basher crap.
Ignore does not prevent the board from being filled. This is not Twitter where responding creates “followers”… they just post until they fill the board. The people who never post complaining about people rebutting the bashers is rich.
Give it a break. Your fake nonsense based on your desire to miscast things is total garbage. You have absolutely no basis to make these claims. You just think if you post it you can convince “idiot retail”…. This is the crap that hedge funds pay well four guess, especially when a company goes much further and than they expected and they need to squeeze that price before approval. Total BS, with your “straight man”… to make it sound legit.
The submission was PR’d. The eMASS system MHRA uses gives them an immediate acknowledgment, which is what the PR was based on. They only get anything subsequently about acceptance if there were problems.
There is not a second, “We acknowledged it previously but we just want you to know we still have it.” Acknowledgment. The eMASS system was supposed to provide that unless there is something wrong.
This I have confirmed repeatedly with various sources.
I agree Doc. The board would be come Yahoo, which is actually what they want. This board has kept people interested and maintained unity between longs in terms of sharing ideas and information, and not particularly pumping. Even for me there are people who say things I find unrealistic, but I in no way think they were paid or are pumping. People have different ways of processing information and different levels of understanding as well as different levels of optimism and different expectations. But it is obvious that there is a difference between those whose motivations are clear and disclose their position and holdings and those who keep it all a secret but reveal their motivations by their nonstop bashing.
They have to go back almost 20 years, to mistakes by PREVIOUS management... who clearly were just in over their heads...
There is no need for the specials program once DCVax-L is approved and in fact you’d not sell a licensed drug under that program.
I think as to already incurred expenses and paying down their account, this is also my opinion. And income recognition may not be immediate as well because of complexities with those incurred costs and also the specials program and the ways in which payment may be received. But I do not claim to know anything.
As a follow-up to that post, and anyone reading this should read the post to which I’ve responded. Dr. Malik was appointed to the Board of NWBO in 2012.
In 2011, he was rated quite highly…
“Navid has over fifteen years' experience within the Pharmaceutical arena and is highly regarded in the Life Sciences equity research sector. He was awarded two StarMine Analyst Awards in 2011, having been ranked as the number one stock picker in the European Pharmaceuticals sector and number two stock picker in the UK and Ireland Healthcare sector.”
“About StarMine
StarMine is a division of Thomson Reuters focused primarily on building quantitative factor models for institutional investors. StarMine's equity analytics and research management tools help investment firms around the globe generate alpha and process equity information more efficiently. They are one of the largest and most trusted sources of objective equity research performance scores. Their performance scoring helps investors anticipate trends in analyst sentiment, predict surprises, evaluate financial statements for measures of earnings quality, and more.”
Advent was a spin out from Cognate which manufactured DCVax-L during the trials and for that reason enabled consistency and the continuation of knowledge already acquired over years. It was brilliant for that to occur. As you likely know but will no doubt deny, shorts manufactured false light based financial havoc for both NWBO and Cognate when they blew up supplier based financing using the shares of NWBO as payment over years. Cognate ended having to sell itself off to CRL: https://ir.criver.com/news-releases/news-release-details/charles-river-laboratories-acquire-cognate-bioservices-create
Being able to retain that knowledge and information developed through Cognate for NWBO, and enable continuity for not the Specials Program and for full commercial licensing was brilliant and foiled shorts in a million unknown and untold ways.
What really pisses shorts off is that even when they blew things up, it created new opportunities to create a new structure for manufacturing, which I explained in my recent previous posts, that angers them to no end… it’s scalable, and NWBO will add automation shortly, apparently, and if you’re a short, that is so disappointing… so, we are playing the “Hey, look over there!” game again. That’s what all the focus on random old news is all about… Hey, don’t pay attention to the application with MHRA or that new PR about Flaskworks, look at this almost 20 year old PR, etc. wasting all of our time…
As for the so called “pumper” on the board, which is total garbage, you mean this gentleman:
https://thelifesciencesdivision.com/about/our-team/
Dr Navid Malik PhD MSc MBA ACSI
HEAD OF RESEARCH AND EXECUTIVE DIRECTOR
SENIOR MANAGER EMPLOYED
Navid is an award-winning stock picking analyst, (Starmine and Extel Rated) recognized Internationally for his work in the biotech sector.
Navid began his career at Williams de Broe – now part of the ING group, before moving to Collin Stewart, later as a partner at Matrix Corporate capital he won multiple awards in the sector.
Dr Malik headed up a number of smaller mid-cap broking firm healthcare franchises where he focused on marketing deals before co-founding The Life Sciences Division.
Image
Two Starmine Awards: Across Europe for stock picking pharmaceuticals and for healthcare UK & Eire (2011)
Navid has lead some of the largest European IPOs in the biotech sector, successfully floating companies onto the London Stock Exchange AIM market, as well as raising billions of dollars of capital. Dr Malik is an extel rated research analyst and continues to write extensive corporate and detailed thematic research on industry.
Dr Malik continues to serve as a Director or Non-executive Director of a number of life science companies.
17
APR
2012
Northwest Bio Welcomes New Additions To The Board Of Directors
Dr. Navid Malik and Mr. Jerry Jasinowski Bring Extensive Experience to the Board
Bethesda, Maryland, April 17, 2012 – Northwest Biotherapeutics (OTC Bulletin Board: NWBO) (NW Bio), a biotech company developing DCVax® personalized immune therapies for cancer, is pleased to announce the addition of Dr. Navid Malik and Mr. Jerry Jasinowski to the Company’s Board of Directors. These new members bring to the NW Bio Board longstanding, deep experience in the life sciences industry, advanced manufacturing, and corporate operations and governance.
Dr. Navid Malik is the Head of Life Sciences Research for Cenkos Securities Plc. in the UK, and has been one of the most influential analysts in the UK and Europe over the last decade, covering the life sciences industry worldwide. In 2011, Dr. Malik was awarded two Starmine Awards (awarded each year by Thomson Reuters and the Financial Times): Number One Stock Picker in the European Pharmaceutical Sector, and Number Two Stock Picker in the UK and Ireland Healthcare Sector. Dr. Malik has built life science teams and franchises at multiple large financial institutions in London, which completed IPOs and secondary stock offerings for small biotech and life sciences companies totaling over $700 million in recent years, and which also initiated research coverage on dozens of small life sciences companies in addition to covering large pharmaceutical, biologics and healthcare companies. Dr. Malik holds a PhD in Drug Delivery within Pharmaceutical Sciences, as well as degrees in Biomedical Sciences Research (M.Sc.) and Biochemistry and Physiology (B.Sc., joint honors). Dr. Malik also holds an MBA in finance.
Yeah, the clip used to be ready available all over YouTube but it popped up prominently when Cramer was getting a lot of negative attention and they had a service apparently go and remove all of them.
You presume just because you know the general details of a contract you can understand everything.
The general terms of their contracts are outlined in their financials. It doesn’t mean you’ll understand or know everything about them.
We have yet to receive their annual report for 2023, but we do know the company has funded development. We also know they cannot market. We do not know how much substantial revenue or when if any, it has come in on the specials program.
We do know that Sawston is the means and Advent is the service provider in the UK. This makes sense since NWBO itself doesn’t do manufacturing, it contracts that service out.
The space leased is not the same it’s the services provided nor the infrastructure built for Advent to provide the services. Advent is under contract. Advent is required to provide the services to NWBO when there is demand, and the requirement under the regional development contract to help other companies would be a cost to NWBO, not revenue. But it does help subsidize the building, staffing and maintaining if a GMP facility to manufacture DCVax-L at reasonably low cost to NWBO and it is a small portion of the ultimately available space.
Effectively, it isolates what would be a serious COST center off of the balance sheet with set costs that are more manageable and that can be symbiotically subsidized, for now, and that facility s the germ seed for the larger facility that will likely use different technology and be automated. It is a perfect launch pad and allows manufacturing to be scaled as needed, which for this are, in biotech, is extremely innovative.
Basic research is the cornerstone of being able to have a rational conversation on matters such as this…
https://nwbio.com/northwest-biotherapeutics-announces-mhra-approval-of-license-for-gmp-manufacturing-at-sawston-uk-facility/
You seem only able to accuse people of bad things and scream lies, and call for people to be banned. This is not rational.
No lies. Just the truth. You appear not to understand what is happening. For instance, nowhere in that contract is there a reference to “royalties”, yet you present it and make such a claim. And then when someone explains it to you, you call them a liar and demand that they be “banned”… quite intemperate and irrational, in fact.
For instance nowhere did I say NWBO owns Advent. Not even vaguely, in any shape or form. Your argument style is intended to distract and you try to get people NOT to read rational answers.
I explained the relationship. It’s a contract manufacturer, a common thing in biotech. But manufacturers who were doing innovative and helpful things with regard to dendritic cells were not so common. Advent is a spinoff company from Cognate, which did the clinical trial manufacturing for NWBO. Having that consistency is useful, beneficial and important. Not for shorts, but for everyone else, yes.
Yes, all of these things have straightforward answers and no, it’s not a scam or conspiracy theory. The fact that there are people who spend their time manufacturing such garbage day, after day, after day, Cho chose basically “marks”, people to convince on bulletin boards, that they are invested in a scam, so that they can manipulate a stock and make money, THAT is disgusting! It should be criminal.
Actually, she had innovative financing in place with their supplier Cognate to keep dilution down very low. Cognate paid for manufacturing, and received shares that were well priced. And Cognate agreed to hold those shares and not turn their costs into cash indefinitely.
The restriction was, and it is typical in such agreements, that if shares were directly offered at a lower price, the shares Cognate held for their costs, which were a dollar amount, would be topped up, so that while they were holding, they were assured that they had full payment. This is called a most favored nation’s clause. They get the pricing benefit of subsequent financiers.
Shorts look for companies that have contracts like this. Then they create false light campaigns to collapse the share price. You can get a whole lot of people participating in such campaigns who are really just day traders also. It’s unfortunate.
They collapsed the price under a dollar, got the company in a position where it had to provide cognate many more shares and caused the issue that they had to issue those shares AND stay solvent, with a much lower share price. Shorts took advantage of these conditions. In reality, they know the company is no “scam” and that DCVax-L is completely legitimate, but they simply do not care and will say absolutely anything to maintain the low price.
The great thing for funds that do these trades is, if they can keep a share price that they shorted like this very low, they can finance based on their portfolio, with their investment bankers, leverage it and keep printing money, without covering or selling. And they can keep rolling forward their tax event for years, and avoid margin calls if their other investments (short positions potentially) are not as lucrative or even “up”, meaning a loss for them.
So sometimes it is critical to delay and defer covering, because the value of it is just too good and then they hope the company fades and goes bankrupt but maybe not for many, many years. No taxes almost forever. For them, it’s such a good deal, it’s almost like it is subsidized money.
And they know these microcap biotechs mostly fail anyway, and that they issue shares to pay bills until they get a drug licensed, which can take many, many years. Shorting them is a gravy train.
Unless they get a protector. And often those situations don’t always work out or last, so they see many opportunities to short.
Actually, she had innovative financing in place with their supplier Cognate to keep dilution down very low. Cognate paid for manufacturing, and received shares that were well priced. And Cognate agreed to hold those shares and not turn their costs into cash indefinitely.
The restriction was, and it is typical in such agreements, that if shares were directly offered at a lower price, the shares Cognate held for their costs, which were a dollar amount, would be topped up, so that while they were holding, they were assured that they had full payment. This is called a most favored nation’s clause. They get the pricing benefit of subsequent financiers.
Shorts look for companies that have contracts like this. Then they create false light campaigns to collapse the share price. You can get a whole lot of people participating in such campaigns who are really just day traders also. It’s unfortunate.
They collapsed the price under a dollar, got the company in a position where it had to provide cognate many more shares and caused the issue that they had to issue those shares AND stay solvent, with a much lower share price. Shorts took advantage of these conditions. In reality, they know the company is no “scam” and that DCVax-L is completely legitimate, but they simply do not care and will say absolutely anything to maintain the low price.
The great thing for funds that do these trades is, if they can keep a share price that they shorted like this very low, they can finance based on their portfolio, with their investment bankers, leverage it and keep printing money, without covering or selling. And they can keep rolling forward their tax event for years, and avoid margin calls if their other investments (short positions potentially) are not as lucrative or even “up”, meaning a loss for them.
So sometimes it is critical to delay and defer covering, because the value of it is just too good and then they hope the company fades and goes bankrupt but maybe not for many, many years. No taxes almost forever. For them, it’s such a good deal, it’s almost like it is subsidized money.
Advent books the revenues because this is not a regular drug sale. It is under the Specials Program and Advent is effectively serving the role of a compound pharmacy in the UK, putting together a treatment that is ordered. There is no “royalty”. There is only fee for services in terms of NWBO and Advent. The fees are in their contracts, but the revenues are ultimately NWBO’s revenues and Advent will get some fee for services. However, there are baseline costs for licensing the facility, managing it and staffing it. It would be similar for their previous CDMO, Cognate, but much more up front costs because it would be at Cognate’s own facilities and it would require allocation of lines that otherwise would go to manufacturing other drugs.
In this instance, NWBO owns the facility, and they have a bit of a symbiotic relationship at this time. Advent provides manufacturing services for regional requests as a part of the low cost financing NWBO received for Sawston to be turned into a manufacturing facility. Advent has a small portion of that facility as well, which can be used when idle, for other requirements and then otherwise is prioritized for DCVax-L.
Anyway, there are costs up front and we literally have no idea how many patients are able to pay, out of pocket, up front and how much. It appears the company has broken up those amounts just to get it all started, and the revenue they may be getting so far may simply be enough to maintain the facility and reduce their monthly burn for having a fully licensed manufacturing facility up, ready and at its required clinical levels even when idle. THAT is always otherwise a substantial cost for companies and I honestly think they do a poor job of explaining just how clever they have been with this, but I get how shorts turn good always to bad, so they just let the circumstances speak for themselves. They have a fully capable factory, that they effectively have possession of, for their purposes, but the costs are shared regionally, because of the regional financing arrangement and requirements. Substantial risk is pushed aside, while they wait to become licensed to market and sell in the UK. Hence the application to the MHRA, which is allowing this drug you claim to be a scam, to be sold at full price to the citizens of the UK, and the UK has stern consumer protection laws and drug regulation. They do not allow such a drug to be provided to their citizens without careful consideration of its likely benefit, even when it is pre-licensed. While the decision is deferred also to the patient’s doctors, they would not allow snake oil to be manufactured domestically, in these circumstances, which require quite a lot of regulation even though it is pre-marketing license being granted.
The end result is the local provider gets paid, manufacturing that compound or drug. NWBO is not licensed to “market” just to allow its facility, and CDMO, to provide the drug, based on that schedule. I am sure we will eventually hear what that requires in terms of payment, and recognition of income. But your speculation appears bizarre and off. Advent has not become a licensed marketer and manufacturer of the drug. No one is marketing it. If the complexity of the situation confuses you, then speculating about it only makes it worse. NWBO owns all rights, Advent is only the CDMO hired to create, license, run its plant and manage the manufacturing processes. Those things do cost money however and this is a facility prepared to manufacture for global demand. For the marketing application to MHRA and ultimately to other regulators, it has to be at the immediate ready to fulfill those requirements.
And as for the UK, given the friendly disposition, a situation I have not seen for any other drug or cell therapy before in any major market, I think the company has the regional financing authority funds and dispensation to deliver DCVax-L to patients, manufactured at a globally licensed facility in the UK, mainly because they have immense confidence in their relationship with the UK regulators. That PIM designation spoke loudly and continues to speak loudly even if it was, otherwise, not apparently all that valuable given the program it slotted into at the time. It symbolized a very positive disposition related to DCVax-L and I believe that disposition has continued to be signaled along the way by all the special circumstances surrounding DCVax-L and patient access to it. It doesn’t mean it is a sign they are already approved. That is a different process and follows its own rules. But it does show positive disposition toward the company and the CDMO and great confidence in their competence and the drug, I believe, and patient and doctor confidence in it. But out of pocket, it is always going to be a challenge for any kind of cutting edge oncology drug like this. People will always need insurance and companies need full rights to scale and meet that demand covered by insurance. That is the nature of this market.
Well, given the post at the end that you shared, I would think he would not be posting until an MHRA decision comes down.
Wow, the shorts are so desperate to get this down and get the volume of selling up, so they can cover, that they are posting articles from as far back as 2010, and raising issues so old, but pretending they are current or trying to make them “current”… it’s incredible. Anyone visiting SHOULD be able to see through that nonsense.
Night is always darkest before the dawn. Shorties may have their way, but events can change on a dime.
And if you want to start only with newly diagnosed and recurrent Glioblastoma, I was able to coax multiple AI’s to generate a rough estimate and nGBM and rGBM based on nGBM cases and recurrence rates. Both came to the same crude but straightforward number of 6080 patients per year. X .45 eligible for surgery, again, crudely, 2736 patients per year
2,736 patients per year x 250,000 crudely, and again my larger estimate goes through and cuts and cuts and does a variety of things to consider the implications of approval also on the market estimate of likelihood of additional approvals and other market sizes, and again, as I said there, these are crude numbers not about actual patients treated by the potential size of the market …
2736 x $250,000 = $684 million revenue.
X 15 for potential market cap, and this does not include all the other brain tumors I think they will ultimately be approved for… $10.26B potential if one were only li tied to UK and used your typical very crude multiple calculation… I used dollars.
Again not an estimate of actual market cap. Given that markets would recalculate likelihood of approval in commonwealth, treaty countries, the U.S., EU and Canada, and the relevant sizes of the various markets, market cap should grow in anticipation of such potential approvals, of course discounted by possibility of rejection, which should, that point be decreasing as a risk factor. Claim what you want… but the reality is, all we can do is consider possibilities, and that’s a good range of possibilities. Not so tiny. And I do suggest people consider the other post and those can of course be refined down further as well. I did some of that in the post. And of course they are rough ideas and numbers and can be further refined and boiled down as I did here. I used the HE potential market size, as I think doctors will want this available for all brain tumors asap. I think the label will be extended, given side trial results like the one planned to be published in Nature, which includes a broader category than just GBM patients. And those patients do incredibly well.
With real world data reforms, extending the label should be possible and the company and UCLA seem likely to have good data to accomplish that on approval. Whether first year or thereafter, I have no opinion. But markets typically look forward in such instances, and again, will estimate likelihood of approval in other markets and the potential markets as a part of a reasonable estimation of future and then present market cap and so will potential buyers or partners consider such matters, and how they could expand markets not just for DCVax-L also, but also for their drugs like Keytruda or Poly-ICLC.
Agreed.
Thanks so much.
I did not say off-label. What makes you think that is off-label?
Brain tumors. The Hospital Exemption was that broad. And they did not even ask for it nor did they have the data now available.
That is the size of the market. The cost for DCVax-Al per month is far below current alternatives. I did not say they are paying $20B. Market cap is a multiple.
There was no off-label assumption.
My point is the SIZE of the market. You can grouse all you want about whether the UK will pay. We will see. The point is it’s about a $3.00 per share market for numerous reasons.
1) it brings along the likelihood of approvals across treaty and commonwealth nations, certainly those in their treaty group as well as Canada and Australia are likely at least;
2) UK and US approvals are usually very much in sync, so it means the market has to presume at that point US approval is more likely than not;
3) EU approval must also be taken as very likely at that point as well. And it’s just a hop from the EU and North America for patients that can afford it and read the news.
Tiny market it is not.
Thanks so much Flipper. Yes, one thing, the UK foreshadows larger approvals and it’s not so tiny when one considers the potential larger number of possible brain tumor patients that could be approved, not unlike the previous approval related to the Hospital Exemption and PIM designations.