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If the science is so derisked why don’t they start another confirmatory study right now with a new trial design? Doesn’t mean the drug can’t be approved with current study through AA. Why haven’t they received BT status already? They will have to run a PMR regardless. Nothing is derisked until we see the published data. Right now the board is still trying to come up with missing pieces in the data they’ve presented.
They have the pinnacle trial up now. Recruiting but only one site so far listed. Hopefully more to come. Dosing seems to reconcile 16mg QD with 8mg BID
What happened to the other secondary end points. I didn’t see them, are they in the updated US registry?
I would be interested as well
As long as they can give just enough detail on data for any long to come up with a hypothesis on the trial regardless that they have the data and that they can openly discuss it, they can continue to dilute and somehow convenience shareholders there is a conspiracy from the shorts.
The only thing I see now is that they don’t want to disclose additional data and there is a conflict of interest on the part of the ceo building out a cdmo with nwbo funds as the first customer.
If there is a working hypothesis that the trial works honest scientist would simply disclose the data and set up a new registered trial with a better trial design. Why not do that with rGBM if it is effective. Start it now. If the data is so good that it will show success the SP will show it or a partner will come forth to pay for it.
How are you going to oust management who has a conflict of interest? They will be fighting tooth and nail to keep what they have and there are no activist shareholders. They don’t even do qtrly conf calls. Lol
The whole of everyone investment thesis wasn’t based on mgmt. It was based on faith in LL who doesn’t have any financial ties. She wants to see the science continue to help patients. She will continue to work on her investigations. It may be possible she works on them separately from nwbo. Who knows?
Thanks Ex for spending time giving us your analysis.
What publication? If there were going to be a publication soon, they wouldn’t have presented the results at NYAS. They would have waited for a tier 1 publication and presented at ASCO. We all know the results aren’t a home run and the lack of transparency will only continue to drive the SP down. Longs here will be selling this week as reality sets in to derisk or take profits. That’s my opinion.
Hi antihama, what do you think of the odac in Sept and the confirmatory study? Do you think the FDA will make them wait until it’s done to approve? TIA
The reality I see is that we have the p3 data disclosed but the company did not PR the p3 data. There is something wrong with this picture. You can say what you want about it being good or bad. But that is still a problem.
I just don’t see a BP buyout without at least one RA approval. Based on the shit show mgmt communication with journal, tld, flashwork, blah blah. I think this continues to fall back to .30s until nwbo files a BLA and gets approval. Nothing else is as material as that. And it appears they did not meet the sec end point of dcvax v control.
As I said before I think the game plan is to enlist outside groups to pressure RAs for approval.
I was just confused as I did not see the control comparison and it was also a secondary end point. Ex explained it though without the data. I see significant risk for holders. But I do wish longs well.
Does anyone know what the dcvax compared to control results are? I didn’t see it on the presentation? Wasn’t that one of the secondary end points?
Biggest problem now is they will go into the ASM and ask for a reverse split and continue to dilute holders. To me it’s not clear based on the presentation regulators will approve right away.
Ex your point should probably be considered in any investment thesis. Is it possible that the delay in the journal is finding one that considers the data post hoc and so either holding off publishing or rejecting the article?
If rol and pozi approved will be a lot higher than 4. Hoping for that before rolo approval.
Absolute beast. GLTA
Btw if demand floods manual production, you would be surprised by what raising hundreds of millions of dollars does to accelerate timelines and reduce risk and try to fill demand. It’s a good problem to have. Not begging for money via convertibles and private placement deals.
Why not publish and inform of the plan. If everything is so great? What would you do?
Assuming management isn’t incompetent, the scenario I find that may be relevant here is:
Trial data is muddy or not convincing by traditional measures or there are some issues in the trial given the length, start/stop, manf optimization changes, etc
Company wants to have a publication that details trial in a way to show benefit. There may be less journal takers?
Have manufacturing automated in a way that the treatment is relatively cost effective
And get public support for approval making it difficult for RAs politically to say no
In this scenario timelines may not be clear.
I find it difficult if everything was kosher for the wait.
I also find that the market cap even after constant dilution, and state of company affairs, still points to the general consensus that the treatment works and needs to be available to patients.
Thanks for the perspective. I’m a little rattled as what nwbo is doing is so far from any professional norm. SPPI is doing it the way other companies do it. There is no real reason to be so delayed IMO.
Are you still in nwbo or shifted some money to sppi? They are close to the same price. Wondering if it makes sense for me to do. The lack of clarity is disconcerting.
That could be true. They could also be a 10 person company making it up as it goes.
I’m staying positive, I’m just saying well planned companies don’t typically act like this. They are likely doing their best but we shouldn’t kid ourselves either.
Did blackrock dump half their position this quarter? Related to Russell rebalancing?
Cohort 3 was first line egfr. I did miss the lower bound slightly. It may be that the BID dosing could do better. Too bad tekada
Already has an approval on a drug in that indication for sec line. It’s possible pozi does better, but idk.
Good luck. These results are good. Looking forward to the rolontis bla and start of pozi confirmation study and fast track for first line her 2.
After so many years a celebration would be great.
What did you think of the pozi data. Do you think they can still be successful in efgr based on 8mg BID?
SP hasn’t really recovered? Are you still bullish?
The fact that the company is almost a billion market cap and very little funds with no transparency by management in the delay is mind boggling.
I’m an investor, but I find the whole thing unique among bios. Most would be sub 100m market cap with RS on the horizon.
It seems no matter what the collective market believes the treatment works.
That would be the cancer moonshot
Thanks for the history. Really appreciate your knowledge and helping me understand this process.
Eligibility for Accelerated Approval and Priority Review, if relevant criteria are met
It seems maybe the fast track designation gave them accelerated approval status rather than priority review. Which is why they are allowed to submit with p2 data and later review of a confirmation study. I’m hoping to hear soon that the p3 confirmation study will start enrolling soon.
Who are the usual suspects and what do you think about this:
The FDA reiterated the importance of having the confirmatory trial substantially enrolled at the time of approval
How are they going to do this in time prior to the approval date decision?
Thank you for your analysis. Let’s hope both pozi and rolontis get approved this year and a huge turn around for Sppi.
Hi Antihama, I follow you on nwbo board. What’s your take on Sppi. I just bought in recently. Seems there is potential. What do you think the chances are for pozi and the market opportunity? Do you have any specific price targets long term?
Thank you
My understanding is that the primary end point is overall survival (OS) not mOS for external control.
Is this correct? Just trying to understand why SOS would make that mistake.
I’ll be looking for signs when you start buying again. I’m a thermo minion.
Great post. Very informative. Many thanks for your analysis.
I will do a virtual toast with you if it all works out!
Great insight. Thank you and your contributions.
Don’t they need shareholder approval for a RS? They haven’t put it to a vote in any of the meetings that I can remember.
Just curious. Did cvm sell shares while on data lock and possession of data?