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First, they didn’t say October at the ASM, next, they didn’t say a request for information had or hadn’t occurred by the ASM, they had been talking about preparing for an anticipated RFI as they had at least two times previously.
What they did tell us in a 10q was that the validation occurred January 24 and validation confirmation occurred March 7. By now, it’s clear a March 7 clock start fits where we are find ourselves.
Then on August 2, they confirmed by then or several days before, that inspections were scheduled. That aligns with the beginning of the last 70 days. That aligns with October 3 being the end of 210 days from March 7.
As LP stated, the process is not exact. Not “on the button.”
Often delayed, but rare occasional early decisions as well.
We are in the window by now. Hope for the best, don’t be surprised by some delay.
You just corrected yourself, declared my need to be right, when just two posts ago, it was you professing to be right. Just try to detach your ego and judgments. Stick to the subject, no one cares about your prowess, they care about the subject matter, and where we are.
First, they didn’t say October at the ASM, next, they didn’t say a request for information had or hadn’t occurred by the ASM.
What the did tell us in a 10q was that the validation occurred January 24 and validation confirmation occurred March 7. By now, it’s clear a March 7 clock start fits where we are find ourselves.
Then on August 2, they confirmed by then or several days before, that inspections were scheduled. That aligns with the beginning of the last 70 days. That aligns with October 3 being the end of 210 days from March 7.
As LP stated, the process is not exact. Not “on the button.”
Often delayed, but rare occasional early decisions as well.
We are in the window by now. Hope for the best, don’t be surprised by some delay.
Whatever info you have, they said nothing about October at the ASM. October makes sense, but windows aren’t that tight. It is Sept 26th. People are reasonable to be watching more closely.
In January 2024, the FDA issued a class-wide boxed warning for all approved CAR T-cell therapies to alert patients and clinicians of the risk of developing secondary T-cell malignancies. The FDA also required updates to other sections of the labels, including warnings and precautions, post-marketing experience, patient counseling information, and the medication guide
https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/fda-requires-boxed-warning-t-cell-malignancies-following-treatment-bcma-directed-or-cd19-directed
Again, the MHRA answer was to another poster’s (albeit reasonable) HYPOTHETICAL question. It turns out he was likely wrong, and that’s not his fault, because he was asked to not to check the specific facts on the ground.
Since that time, the inspections (which normally occur during last 70 days) were scheduled for future times by what would be within seven days of initiation of the last 70 days of the start date (August 2) if March 7 were the clock start date.
By September 6, MHRA had granted Human MIA certification for commercial manufacturing.
The facts are consistent with a March 7 start time. I referred to Sent’s understanding as a “rumor or whatever” but it appears to fit the timing better than the MHRA’s hypothetical based answer.
Again, the MHRA answer was to another poster’s (albeit reasonable) HYPOTHETICAL question. It turns out he was likely wrong, and that’s not his fault, because he was asked to not to check the specific facts on the ground.
Since that time, the inspections (which normally occur during last 70 days) were scheduled for future times by what would be within seven days of initiation of the last 70 days of the start date (August 2) if March 7 were the clock start date.
By September 6, MHRA had granted Human MIA certification for commercial manufacturing.
Car-t used primarily to treat blood cancer (less than 10% of cancers), and primarily target antigens on both cancerous and healthy b-cells. Car-t causes secondary cancers. Car-t received a black box warning. Car-t recurrence rate versus cost very very concerning. Car-t production still a concern seven years after approval.
Yeah, Car-t was/is your grandparent’s tech. Perhaps one day it will improve.
This isn’t your grandparent’s tech and IP.
And you are wrong, biotechs have been acquired for more than 2x premium.
And, without manipulation, MC could rise very rapidly with regulatory advancements.
Bps snooze, they lose, imo.
Go back to kindergarten. I said “nearly.”
And yes, Eli Lilly (LLY) is close to becoming a trillion-dollar company:
Market cap: As of September 2024, LLY's market cap is approaching $900 billion.
878.73 billion
USD
Market capitalization
Somehow you’re wrong. Go figure.
Personally, if you just go from a simplistic product pipeline, in terms of acquisition minimum totaling,
1. DCVax-l = 7.5B
2. DCVax-D = 7.5B
3. DCVax/Poly/CI = 7.5B
4. DCVax/CSF1R/Poly = 7.5B
5. HyperactiveDC (and various future combinations) = 7.5B to ?
= 37.5B
All DC Production ultimately facilitated through NWBO’s Flaskwork’s highly patented closed system automated production.
= ?B
One way to pencil it out for now. JMHO
Swoop. IMHO, if a certain BP (or perhaps BPs) pussyfoot(s) around, there is one nearly trillion dollar BP or another half a trillion BP that could easily swoop in and give NWBO’s science and commercial promise a home/launchpad, imo. Neither of these much larger BP would need to flinch at acquisition cost, and perhaps, providing wholly owned subsidiary control to our scientists, closed system manufacturers and collaborators. Tick Tock.
I remember that there were two levels to this. I think, years ago, some thugs from Hungary or Ukraine were hacking PRs to news agencies. Clearly illegal.
I also think some people get pinged (from whom I don’t know) a PR was sent for release after some company sends it to news agencies for next morning release (after the bell), but no idea if this is true or if it’s legal.
Anyway, on stuff like this, I just don’t know at all.
I don’t know, I just wonder how someone got the market makers to respond so quickly to them. That’s what really caught my eye. When I buy, it’s like molasses. Today was like molasses, then boom, on seemingly no news, boom, the market maker moves like ⚡️.
And if that was, and lets pretend it was hacked and read, we still would not know if the purpose of the trade was to cover, short or what?
Actually, your spin is too dark. If it was something to do with a financing, NWBO might not know the very next day or whatever, let’s say, they would get a decision. If so, they have to keep the lights on, so another financing would not necessarily signal some longer wait, it just means the bills are due?
I don’t know if anything was awry, but it seemed odd.
Probably will become a little more clear in three to four business days?
Thanks. Apparently this series of 75k trades were all transacted in one second. Does that speak to high speed trading, or is that still normal even though historic volume all day did not dictate that?
Maybe it’s one of those P.I.P.E guys hammering the price down to get a better financing term?
I think estate planning is just estate planning. People do it when they get older.
Thanks. Well the trades were apparently all facilitated during the same second.
Question Below: Nothing was turning over that fast all day, so the seller and buyer were likely simpatico.
Can a short do this to cover?
Buy market 75000 shares
Sell it back himself at a lower cost 75000 shares
He buys what he just sold again to cover 75000 shares
Sell it back to himself at even lower cost 75000 shares
He buys again to cover, etc????
Good one.😆
OK then, let me try one on you, just for fun.
Confirmation Validation MAA was March 7.
210 days (150 + 60) added = October 3.
Question: Where did Adam and Eve live before being evicted?
Hint: Rosh Hashanah (Celebrated this Year on October ), also comes from Hebrew and, most simply put, means “beginning of the year.” Rosh Hashanah not only marks the new year—it also honors the creation date of Adam and Eve some (allegedly) 5,700 years ago, the first relationship, and the human connection with God's world.
🙂
Answer: Eden
What they can see is NWBO is going to the correct regulator first for their circumstances, and they will expand manufacturing to the U.S when Eden is ready. IMO.
I don’t think EDEN is ready yet to have the chance to ramp to eventually meet demand, particularly if DCVax-l is SOC. Of course DCVax-l is treating an urgent medical need.
You just proved my point. The FDA had to make exceptions whilst considering demand, and while again, I’ve never come close to stating 100% demand capacity must be set before approval, I have stated capacity needs to be able to ramp in consideration of demand. You didn’t think meeting demand with capacity played a role in approval at the FDA. Now you are starting to see what I mean.
One can expand feasibly in the U.S. with Eden, once it’s certified.
From your AI quote:
Thanks, March 2024 fits my general recollection.
My condolences, I’m so sorry for your loss and your friend’s pain.
“Relapsed”
BTW: Yescarta
The FDA updated the approval for Yescarta (axicabtagene ciloleucel) in April 2022 to allow it to be used as a second-line treatment. This was the first time a CAR T-cell therapy was approved for use as a second-line treatment.
In other words, still not SOC.
Your examples do not address cancer medications and Dr. Pazdur’s (FDA) concerns with capacity on an incoming anticipated new SOC.
Sorry ex, you didn’t answer the question, and capacity challenged Car-Ts like Yescarta are one reason why the FDA is looking at ramping capacity ability before approval.
Feel free to read matters as you wish. I read it differently. If there is something we could possibly agree on, it’s that 100% full scale production readiness is not necessary for FDA approval. However, capacity does play a role (more so if the biological is expected to quickly become SOC). Let’s just take your contention to the other extreme. If a manufacturer could only serve one patient per year, the product would not get approved, correct?
ChatGPT
However, if a biologic is expected to become standard of care, there might be additional considerations:
With the MHRA. Initially.
That is my recollection as well.
Do u happen to recall the date that NICE site (specific title) change was made?