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CYRX down in the last couple of weeks, without any substantive news.
Staying long.
Best of luck with your investments!
Houston again, partnering with Takeda's BioLife Plasma Services
The Houston location will help the partnership synergy.
Cryoport Enters into Strategic Relationship with Takeda's BioLife Plasma Services
Cryoport plans to establish an integrated supply chain platform with BioLife Plasma Services to offer standardized cell therapy collection, processing, and storage services in United States and Europe over time
Nearly 4-year median overall survival benefit in the radiation-only group
Yep, not too shabby.
Bought another slice at $1.09! The MC is < $250M!!
I would believe the MC will largely exceed $250M post approval, a very likely event.
Best of luck with your investments!
Thanks DavidW2
I must say they are an exception in the biotech world. They hit their target dates pretty much every time. And they exceeded expectations on this one.
https://ir.outlooktherapeutics.com/news-releases/news-release-details/outlook-therapeuticsr-re-submits-biologics-license-application
101.7 month vs.. 55.2 months mOS
Rather impressive.
Benzinga Article
https://www.benzinga.com/markets/penny-stocks/22/08/28663723/cvm-clinicaltrials-submission
A good recap of the situation, the basic trial data, and the next steps, including:
Bought another slice at $1.14
September coming soon to a calendar near you.
Best of luck with your investments!
NWBO End Game Chess Moves
1) NWBO does not sit on their hands, that's for sure. After Manufacturing, they are getting their ducks lined up for MHRA, and they submitted the PIP back in Feb. 22. That takes work to put that together and get it through the regulatory process.
Yes, that was indeed the sense of my posting the Company's paragraph.
Best of luck with your investments!
Pre-specified in the original study protocol and in the SAP.
IT-MATTERS Phase 3 Trial Results Summary
Results Submittal Timeline and Expectation
Here is the timeline of results submittal and how long it took each time for CVM to respond:
It went from a few weeks to a couple of weeks to around a week to now the same day.
I think they fixed the last remaining issues and the Aug 17th rejection was due to minor details. I think this is the last submittal before the OK and the result publication on https://clinicaltrials.gov/ct2/show/results/NCT01265849?cond=NCT01265849&draw=2&rank=1&view=results
The time for that OK may still be one month. So my expectations is that around Sept. 17th (that being a Saturday), we will have the results published.
Best of luck with your investments!
Expected Timeline
> On March 31st, 2022, the BLA was submitted.
https://ir.outlooktherapeutics.com/news-releases/news-release-details/outlook-therapeutics-submits-biologics-license-application-us
> On May 31st, 2022, the Company announced the FDA decision wrt the BLA:
https://ir.outlooktherapeutics.com/news-releases/news-release-details/outlook-therapeutics-provides-update-biologics-license
So we could reasonably expect something along those lines:
> Submittal September 30th
> News on BLA submittal approval or new rejection November 30th
That's when I expect to know if we are on sure footing for a PDUFA date without any more back and forth. I don't expect an AdCom as the product is 'already' used in effect. So I expect a straight PDUFA date with an up or down decision, probably Q3 2023, and very likely up, launch to follow Q4 2023.
Best of luck with your investments!
Keeping to September 2022 Resubmission
From the August 2022 presentation:
Two US Based Global Supply Chain Centers, Houston and Morris Plains!
Belgium Cell Matters acquisition
After France Cell&Co earlier this year, CYRX acquired another EMEA company:
Yes, one the neurosurgeons who endorse DCVax. You may have heard of them, they treat GBM patients. They see the results. Those are the folks who endorse DCVax.
CYRX: Earnings Call Aug 4th:
The effect of the fire earlier this year should start to dissipate and the backlog could even boost this quarter's earnings.
Also curious about the distribution and volume of PI, PII, PIII and Commercial products supported.
Best of luck with your investments!
From $32 to $42 in 6 months. Not too shabby!!!
Aug 4th is the Earnings Call for CYTK!
NJ Common Pension Fund D Acquires 6,275 Shares of Cytokinetics
More excellent news for NWBO!
After the NYAS talk, manufacturing lining up, patents. All bodes well for NWBO!
Best of luck to Patients, NWBO, and Longs!
I went back to my emails with Dave Innes as this reminded me of a short exchange.
In one of them, dated June 7th, he answered one of my questions with
"Peer review. "
This makes sense. May 10th is most likely right.
Thanks again hoffmann and biosectinvestor!
Best of luck to Patients, NWBO, and Longs!
Thank you both.
Cheers!
Thank you hoffmann,
I can see how one could interpret that remark as pertaining to the 'new' article NWBO Longs are waiting for.
I thought (still think) Dr Brem was referring to the 2018 article, where he is one of the (69) authors :
https://translational-medicine.biomedcentral.com/articles/10.1186/s12967-018-1507-6
I hope your interpretation is the right one though :)
Best of luck with Patients, NWBO, and Longs!
Hi Red_Right_Hand,
I skip over most posts these days, so I missed the info on a submitted article.
You write:
AdCom scheduled for December 13, 2022.
The NVCR spokesperson is at it again. You wonder why he bashes NWBO? I don't.
PDUFA now Feb. 28, 2023
Your new profile pix is pretty good :) Thanks for the smile!
Best of luck with your investments!
Hi Swampboots,
Check out their corporate presentation:
https://ir.outlooktherapeutics.com/static-files/10b909de-a80a-45af-a98d-470ce9f068ef
Especially slide 9 and 10. They also have good videos.
Best of luck with your investments!
September resubmission confirmed
The Company issued a PR reiterating the September resubmission timeframe:
Hi Senti, is it another rabbit out the hat ?