The timing of the MAA and MTD decisions should be interesting to say the least. I would surmise to say that an MTD denial before an MAA approval is more favorable than vice versa. At the current rate that may happen.

BTW - Roche just ended a trial after Keytruda was described as delivering a "knockout punch" based on, yup, "data from real world evidence."

Continued - After all, Keytruda is practically treated as if agnostic: https://www.merck.com/news/fda-approves-mercks-keytruda-pembrolizumab-plus-carboplatin-and-paclitaxel-as-treatment-for-adult-patients-with-primary-advanced-or-recurrent-endometrial-carcinoma/

Chiugray, I don't rule out anything. Maybe, perhaps, it's taking longer, because we're on the verge of a tissue agnostic level approval. Who knows.

More than happy. Ecstatic💪💰🔥🚀📢

attila - Dark forces aside, for them, the train to stop, injure, or delay dcvax has long left the station. So much so, that we're finally, against all hostility, which is an entirely different matter to wrap one's mind around, seeing the train arriving at the station. There's too much track left behind and too little in the front to miss its huge arrival. Much to the disappointment to those who meagerly believe, that their thoughts or fantasies from basements, benches, Starbucks, tent cities ...of seeing a different outcome is just that, only in their own twisted minds.

Once dcvax is recognized as tissue agnostic, and finally despite special interests to keep chemorad going $$$$, dcvax has a real shot at being that ubiquitous starting point, and bases for additional modalities to tweek per patient case, based on the recently evolved diagnostic platforms to individualize options.

Alternatively, BPs release very expensive drugs in an already crowded space consisting of effective treatments, marketing them as an option to take with less frequency. Say once a month for $14,000/mo over the weekly option at $9,000/mo. That's a tough sell to payers.

Kite BO $12 billion for a rare blood cancer. 🤔🤯

Check out @Paffus message on Stocktwits http://stocktwits.com/Paffus/message/578495969
Check out @Paffus message on Stocktwits http://stocktwits.com/Paffus/message/578496352

DD - I couldn't have said it better. Thanks for saving me the trouble. 🙌🙌💪👍💡🎤

I see. Maybe you can join the MM's defense team, cause they're not doing too well. Heck, someone with Posner's impeccable resume, somehow decided to flush her career down the toilet.

Agreed. The franchise vision pits the BPs against each other, while the tissue agnostic platform is ubiquitous. 💪

BP's has vast resources, but imo, BP's way of perpetuating illness, as a business model, has become old, and the public has become far more distrustful of BP than ever before. LP had a very good point in an earlier ASM, when she described BP as merely a checkbook. LP exempified the divergence of her innovative approach from the dated status quo model, and it's not hard to see that BP lacks vision.
There's a huge advantage to being, let's say a nimble, strategic company, that could certainly employ more people to fill out key positions to remove inefficiency, while at the same time continue to trail blaze and transform healthcare as we know it. Maybe BP had one two many strings attached, and perhaps large capital outside of BP can recognize the vision, especially now that NWBO is way beyond proof of concept in pharma years.

dstock - Yes, too many synergies to ignore. 👍

Cart -T 50 patient treatments per annum at the beginning. LP didn't condition initial approval on a Flashworks closed process, but did say, their objective would be to transition expeditiously.

Only Management is not involved with the application process. It uses teams of leading industry consultants.

Do I hear 7 digits, going once.. twice..?

Imo, it's pretty clear, LP must have BP "coming and going," and "scratching their heads." I bet BP(s) is/are the client(s) behind the MM's spoofing, and suppression of NWBO sp. It must be why MM's are fierceIy trying to protect their clients identies. I'm more than casually aware of BP's dirty antics, and I know, you can't put anything past them.

I suggest revisiting the ASM transcript if, for anyone falling back to tree staring. Prerevenue biotechs have fetched billions, as run-of-the-mill, single bullet gambles, with minimal data to substantiate their potential effectiveness. So if you want to understand, or find an example of what 20 years of development should show under the hood, go through the transcript. LP was right when she said, "the heard is years behind."

BTW - I can't stress enough how advantageous LP's and LG's DC connections are. DC is the filthiest swamp ever known to mankind, and being on the right side, through experiences on the inside is invaluable. I suspect those relationships came in handy over the years, and the addition of Cofer, at minimum was a show of force, a signal to the underworld that NWBO is watching. True to form, LP played her hand close to the breast, hired the best council, and pulled the trigger at the right time. Is it a coincidence that the MTD is in the Judges hands, at a time, when she has everything else line up like ducks at a shooting range. She's brilliant.

I went back to look at the additional commentary from Bigger. You have a point. Heavy on the banter not much of anything for solutions. A buffoon would neglect addressing the manipulation. How many CEOs does he know that had, or currently has the balls, to go after 7 market makers, and the patience to collect evidence over five years, and BTW while in stealth mode. So no yapping. Just attacking. Wait, I thought that was his big ask. 🤔 Another Monday night quarter back, who let's his frustration out on the wrong side of the equation. Croc's, Energy... Really? Sounds like he's due for a reality check.

Michael Bigger actually posted the ASM audio on Twitter, as a means to give those who were not among the 600 an opportunity to listen in. He was impressed with LP's explanation of Flashworks advancements etc.

Zadie - Look up average MAA page count. I'm pretty sure I saw 500,000 as a base minimum.

I was correct. Baker Brothers and Sandler, and I didn't finish reading the article, both funds have invested in OTC. BB invested $50 in Sky Biosciences....
https://investingwhisperer.com/a-potential-multi-bagger-in-small-cap-biotech/

I'm not sure, but I believe Baker Brothers has invested, though minimally in OTC biotech.

IMHO, Management moved mountains to overprepare the MAA to such an extent, which likely covered every possible area that could warrant a question. One thing is certain, nothing was rushed, skipped over, or left open for interpretation. No expense was spared to put teams of leading experts to handle sections of the vast application. Imo, it's possible to put an application together, that is so buttoned down, that it could avoid an RFI. Even if the regulators are sophisticated enough to find a question to ask, it's likely to fail to resonate among the regulator team, to such an extent worthy of a clock stoppage. In this case, the expression, "there's no such thing as a stupid question," need not apply.

Kite is a blood cancer treatment. There's no sophisticated apparatus there that needed herculean development. It's apples and oranges.

Manibio - Speaking of burnt, don't you think it's odd that a BP paid $12 billion for Kite, when it's addressable market is a nothing burger? Analysts to this day are baffled. I believe it's the same with EXAS as well. At least for me, it's certainly a good reason to pause and look at the landscape to assess expectations, and what they're are based on.

History has also proven that "operation warp speed, and or so called "fast track." in practice, leads to failure. This slow, but painful advancement is ensuring an enduring instruction of a practice changing treatment. That's the business we chose to invest in.

If the answer is dcvax, when asked, "what treatment would you seek if you were diagnosed with GBM?" Then know the market will come to NWBO. That's why I sold Amrn, because no matter how fantastic, adding 25% ARR of a Cardiac Event and or Stroke, which is on top of the 25% ARR, when taking a statin alone, Vascepa should fly off pharmacy shelves, but they're not. Sales are flat. Worse, patient compliance drops off by 50% after six months. That's why CVD is called the silent killer. There's not enough fear, pain, and disability, sadly, when addressing prevention. Astonishing, but true. You need to scare the bejesus out of people to change their behavior patterns apparently. 4 years after approval, and physician awareness is flat.
GBM is as scary, debilitating, and terminal as it gets. So one way or the other, all roads lead to Rome.

This is true. My brother was SHD explaining that he saw, "maybe two patients a year" in his high volume practice with that type of cancer. How did BP justify paying $12 billion for a nothing burger market?

$NWBO Remember: Kite was bought for $12 bn in 2017. They had applied for one indication for B Cell Lymphomas that had relapsed after SOC, a small indication. Through 2023 only 13,000 patients treated. We’ll get off the OTC and grow quickly, be worth 4 x’s Kite was; or more.

— Gregory Zivic, MD (@metacollectiveG) July 2, 2024

If you start walking now, if it's not dark yet, you might find the forest.

The ASM date was strategically gamed out. The idea was to be as deep into the review process as possible in order to maximize possibilities that were well anticipated.
- In the best case, we may have enjoyed receiving an approval before the meeting.
- No approval going into the meeting would provide shorts their last opportunity to sell the news.
- LP takes the opportunity to tee up all the groundwork information around manufacturing. She provides deeper insight into the value of that stealth deal, and therefore the missed opportunity for shorts to sell the news.
- The MTD decision is in the Judges hands.
- We are far closer to announcements that will come as PR's in succession in shorter intervals.
- NWBO is gathering momentum and will soon be knocking on the door of an up-list. Like her stealth deal with Roswell, don't expect the up list to be in anyway, telegraphed!

Yup, one would think.

But yes, if one is generally a pessimist, which I am not one, will go on and on assuming the worst case, until the moment it comes to fruition.

Understood. But let's agree that besides the fact that applications are yet to be reviewed, or presently nearing a decision, approvals are taking place daily. As a matter of importance, since we have already exceeded the 150 days as you've pointed out, it's far more likely on that metric alone, that an approval can come at any moment, and it's not so clear as to assume any protracted period is likely.

I'm actually saying that the metrics is a bit too generalized. How many new talcum powder formulations, we didn't know we needed, or how many of anything in an already crowed space are in there? So when they talk about over 1,000 plus backlog, what exactly are they referring to? It absolutely matters.

WOW, since you put it that way?

There it is 6. Do I hear 7?