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Neuro-oncologists never saw any patient alive at 5 years in the External Controls
At 5 years, on the External Control group, it's all LFTU. Whatever happened to them, that means the surgeon who treated them never see an alive patient at 5 years in the 1366 they treated. Either they are dead, or there are no contacts with the patient (they are dead is the vast majority if not *all*).
Now here are patients who survived 10 years, 15 years. They will see Brad Silver and others from the DCVax trials who are still alive at 5 years. No wonder one of the neuro-oncologist gasped at the sight of the data.
Best of luck to Patients, NWBO, and Longs!
Hi Hopeforthefuture3,
Bad cut&paste of the title (a bit too many 'paint' variations at the same time). The second graph is for the "Overall Survival in Newly Diagnosed GBM" , i.e. slide 29. I hope the rest is correct :)
Cheers!
Hi dmb2,
I believe the At Risk numbers were placed together with the KM curve for that exact reason. The folks at UCLA and NWBO are savvy.
Cheers!
Hi Cherry Tree,
ABeta's number from Project Brain Cancer show 0 survivor with SOC at 60 month. Zero. Whatever the state, the original number, big or small. Zero.
All the slides from the study show two things: for SOC/External Data:
* At Risk Patients: 0, for all categories
* KM Curve: some non events still pushing the KM curve (5% for one, etc.)
Now if it's 0 at risk, it means *all* the KM curve for that point are made of LTFU. All of them.
My contention, given abeta's numbers, is that they are all dead. It's an awful disease. SOC, think Chemo side effects, and at 5 years, you are dead.
I made the same assumption for the DCVax numbers: All LTFU are dead. Now, DCVax AtRisk patients (ALIVE) is 25 for one, etc. So a significant difference.
DCVax is the only hope at this stage.
Hi abeta,
The numbers at risks are not the numbers from the KM curve, which is used in slide 30 (and 40 for that matter).
At month 60, for all the curves, the number at risks is 0. In a nutshell, the KM at that point shows *only* the lost to follow up, i.e. people who died. Because they are 'lost', there is no event on the KM curve. Maybe they died at month 29, maybe at month 41, you just don't know, they are lost, they can make it to the KM. You may argue that a few were still alive at month 60. My take is they all died. The numbers you provided from Project Brain Cancer made it super clear.
I assumed that the "5% or less" survival given for years at 60 months for GBM where from actual patients, they are all from lost to follow up. That number is all 5% were lost to follow up. They all died.
Those folks followed SOC! Now, if they followed SOC with a prognosis of sure death, I am convinced they will add DCVax with hope of actual survival, like Brad Silver.
SOC: 0% survive at 5 years.
See posts:
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=168845114
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=168844390
It's an awful death sentence. I'm a bit in shock. The only real hope is DCVax.
Treatment arm 5 times better Control Group
The fourth secondary objective, OS, is overall survival compared between subjects randomized to DCVax®-L and those randomized to Placebo within Study 020221.
GBM SOC is a death sentence at 5 years; DCVax wins.
Your data confirms what I was teasing out of the slides, https://virtualtrials.org/dcvax/dcvax.pdf
Slide 29: At Risk: Start with 1366; Month 60: 0
Slide 32: At Risk: Start with 45; Month 60: 0
Slide 33: At Risk: Start with 184; Month 60: 0
Slide 35: At Risk: Start with 210; Month 60: 0
Slide 36: At Risk: Start with 199; Month 60: 0
Slide 37: At Risk: Start with 349; Month 60: 0
5 years at risk: 0. All the time. When I heard before up to 5% survive at 5 years, I did not realize those were *all* lost to follow up, meaning, dead.
This terrible disease is a terminal death sentence.
You add DCVax: you get 10% at risk, i.e. 25 out of 232.
I'll repeat that.
Out of 1366 patients, 0 survived without DCVax
You are confirming what I thought abeta.
DCVax is an incredible technology. You'd rather have 0% change of surviving, with Chemo (!) at 5 years, or 10%.
At Risk Numbers v. Graphs
Dr. Bosch kindly answered my question (Thank you Dr. Bosch!). Here is the quote:
"All the numbers are correct. The numbers under the graph are 'patients at risk', which means the patients that are still in the picture after subtracting the patients lost to follow up and the patients who died. In the control population there were many more lost to follow up because not all trials followed patients for the same amount of time. "
Below is my take on things, not Dr. Bosch's.
The DCVax already excellent results are probably underestimating the improvement of DCVax v. the External Controls group.
These subtleties may be lost on a number of people seeing the graphs. I believe that in effect, the External Controls group shows the actual events recorded, as if the 'lost-to-follow-up' patients are considered not eventing and surviving.
In such a devastating disease, I would venture that the number of 'lost-to-follow-up' patients who survived is small. In other words, the graphs are showing the optimal curve for the External Controls group. In other words, the worst graph for the Ph III DCVax-L study.
A friend of mine, "T.F." , took this an extra mile and overlaid the number at risk on the graph as a blue set of lines, in the worse case scenario for the 'lost-to-follow-up', i.e. they all died. This is what a couple of graphs look like.
That's quite a difference. The 'reality' of survival is somewhere between the 'blue' line and the External Controls KM.
Those already excellent study results are in fact from a worst case scenario with regards to 'lost-to-follow-up'.
See slides p. 30 and 40 (like the one below) are again probably underestimating the improvement of DCVax:
Best of luck with your investments!
Hi Chees,
I already did earlier. Got an answer from Dr. Bosch. No time tonight, will try to get things clarified for the MB tomorrow.
Cheers!
Hi j e d
Actually, I know what's going on. No time now, but I'll post an explanation tomorrow, probably with another graph :)
Cheers!
Thank you, Thermo.
Priority review would be a plus :)
I may be getting monies on a company liquidity event here at my work. depending on the timing of the event and PPS at the time, I'm thinking of investing more in OTLK. Your thoughts are greatly appreciated!
Best of luck with your investments.
Hi Thermo,
Would you have any insight as to the acceptance of the BLA by the FDA (not the approval, but that acceptance of the filing / they are OK to work with it to set up a PDUFA)? The filing was announced on March 31, 2022.
https://ir.outlooktherapeutics.com/news-releases/news-release-details/outlook-therapeutics-submits-biologics-license-application-us
I understand if you can't divulge certain information.
Best of luck with your investments!
Dang you are good Senti!
Graphs v. Numbers: Some Errors?
Looking at the numbers provided with the graphs, it seems the graphs look worse than the actual numbers. For instance, take Slide 29 numbers to get a % survival. Those percentage are shown on top of the original slide, with the location of differences on the graph.
It does not quite line up with the graph (esp. the external). It makes the external look better, hence the overall results look slightly worse.
Flipper: Thoughts?
Dr. Mulholland started his talk with words like "exciting", "landmark", great data coming up at past 11:12 am, honored to be part of this study, he saw the benefits with his patients, before even talking about the data past 11:30 am.
I don't think those words are in line with the plunge before the data reveal.
The Drop Started Before the Results Presentation
Dr. Mulholland talked about the trial results after 11:30 am Eastern. And yet the big drop had started before that, the big push being at the start of his talk. You can see on this Fidelity capture the black dot at 11:26 am and how big of a drop was already 'achieved'.
Dr. Mulholland took a while to get to the data. He went through a number of slides around trials. The results are only on slide 24+. Maybe around 11:30 or later if I remember correctly.
https://virtualtrials.org/dcvax/dcvax.pdf
Draw your own conclusions.
Bought more shares today.
Commercial Outlook - May 2022
We expect another year of continued commercial revenue ramp as our clients focus on expanding their commercial manufacturing capabilities, as currently approved products receive supplemental approvals for new or expanding indications, and as anticipated product launches come to fruition.
Two (2) Cryoport supported Biologic License Applications (BLAs) or Marketing
Authorization Applications (MAAs) were filed in first quarter 2022, based on internal information and data from the Alliance for Regenerative Medicine.
During the quarter, there were three (3) approvals consisting of
> one (1) new product,
> one (1) geographic expansion and
> one (1) move to earlier line treatment.
Currently, we anticipate up to an additional fifteen filings, three (3) new
therapy approvals, and an additional seven (7) label or geographic expansion approvals in 2022.
For 2023, another 20 BLA or MAA filings are anticipated, up from twelve previously.
Thanks for the NYAS communication iwasadiver!
Best of luck to Patients, NWBO, and Longs!
Q1 Earning on 05/05/2022 - Confirmed.
Best of luck with your investments!
Bought more in the $22, so not completely playing with house money, but pretty close :)
Upcoming CC this week. The current valuation is way too low.
Best of luck with your investments!
Hi BigHeis,
You can see the SEC filings directly from the Cel-Sci site:
https://cel-sci.com/sec-filings/
The letter in question is the 14-A of April 29th.
You should be able to receive CVM news notifications by registering. See https://cel-sci.com/new-investor-information/.
Best of luck with your investments!
Oppenheimer :Price Target to $57 From $53, Maintains Outperform Rating
HC Wainwright: Price Target to $75 from $69, Keeps Buy Rating
And the PPS goes up 11.5%
Could be in anticipation of the upcoming Q1 call on May 4th.
Best of luck with your investments!
ASCO Abstract: Leukocyte interleukin injection (LI) immunotherapy extends overall survival (OS) in treatment-naive low-risk (LR) locally advanced primary squamous cell carcinoma of the head and neck: The IT-MATTERS study.
See: https://meetings.asco.org/abstracts-presentations/207201
Author: Eyal Talor PhD
See: https://cel-sci.com/management-team/#eyal
Best of luck with your investments!
Thanks pfelgueiras!
As guesses go, this one some merit!
1) https://seekingalpha.com/article/4480794-outlook-therapeutics-fda-approval-possible-buyout?mailingid=26453681&messageid=must_reads&serial=26453681.108183&utm_campaign=Must%2BRead%2BJanuary%2B22%2C%2B2022&utm_content=seeking_alpha&utm_medium=email&utm_source=seeking_alpha&utm_term=must_reads
Posted by VMLG17 on this board.
2) I have seen in the last 10 years of looking at biotech BO's after BLA and before PDUFA
3) That PR you provided states "The BioLexis reorganization, which does not entail any changes in the indirect ownership of Outlook Therapeutics, provides GMS Holdings with increased flexibility to support the future growth of Outlook Therapeutics as its largest shareholder. "
A BO is at least conceivable. I wonder if the current PPS is ripe for it and what the Buyer would be willing to go on top of the current pps.
Best of luck with your investments.
OTLK @ Eyecelerator / ASCRS 2022
The Outlook Therapeutics team will be at Eyecelerator @ ASCRS 2022 today in DC. See you there! For more information on $OTLK's ONS-5010 ophthalmic bevacizumab, visit https://outlooktherapeutics.com #WashingtonDC #wetAMD #Eyecelerator
@Eyecelerator
#ASCRS2022
The Outlook Therapeutics team will be at Eyecelerator @ ASCRS 2022 today in DC. See you there! For more information on $OTLK's ONS-5010 ophthalmic bevacizumab, visit https://t.co/UDq2ox30fb #WashingtonDC #wetAMD #Eyecelerator @Eyecelerator #ASCRS2022 pic.twitter.com/q0x1V8Zvwo
— Outlook Therapeutics (@OutlookTx) April 21, 2022
And better than grapefruit juice? Monsieur FUDster is back... Why? Preparing another hit piece?
Cell&Co BioServices acquisition: growth strategy.
CYRX is not kidding around. They are building a juggernaut. The latest acquisition:
Acquisition of Cell&Co BioServices, Clermont-Ferrand, France, accelerates Company's EMEA expansion plans and development of its Global Supply Chain Network
NASHVILLE, Tenn., April 18, 2022 /PRNewswire/ -- Cryoport, Inc. (Nasdaq: CYRX) ("Cryoport" or the "Company"), a global leader in temperature-controlled supply chain solutions for the life sciences industry, today announced that it has acquired Cell&Co BioServices, headquartered in Clermont-Ferrand, France with additional operations in Pont-du-Château, France. Founded in 2012, Cell&Co is a bioservices business providing biorepository, kitting, and logistics services to the life sciences industry. Its accreditations include ISO 9001, ANSM (Investigational Medicinal Products), NFS 96 900, and soon, ISO 20387. Supporting its biostorage and services of clinical and commercial biopharma therapies, Cell&Co has in-house QP services.
In 2021, Cell&Co recorded revenue of approximately €2.6 million. Cryoport's purchase price for Cell&Co was €6.2 million, comprised of upfront consideration of €3.6 million in the form of cash and Cryoport common stock, plus a potential earn-out of €2.5M based on achieving certain financial targets.
Regarding the acquisition, Jerrell Shelton, Chief Executive Officer of Cryoport, stated, "We are indeed pleased to have the Cell&Co team as a part of Cryoport. Cell&Co will play a significant role in Cryoport Systems' development of its Global Supply Chain Network, designed to meet the needs of the growing Regenerative Medicine industry worldwide. In fact, on a global basis, industry experts expect that between now and 2027 approximately 30 to 50 new cell and gene therapies will be introduced into the market each year. Cell&Co's competencies combined with its location in the centre of France makes it an excellent strategic fit for Cryoport Systems and will accelerate the expansion of its new Global Supply Chain Network by approximately two years.
"Coupled with our new Global Supply Chain Centers in Houston, Texas and Morris Plains, New Jersey, Cell&Co will add significantly to the development of Cryoport Systems' global service offering. It will also provide Cryoport Systems with an EU site for importation services for non-EU clients, which will add significant value for our clients and create additional opportunities for U.S. based regenerative medicine developers looking to conduct clinical trials or commercially distribute cell and gene therapies in EMEA."
Sofien Dessolin and Florent Belon, founders of Cell&Co BioServices made a joint statement saying, "The cell and gene therapy market is expected to grow rapidly and is a significant focus for us. We are proud of the work we have accomplished and even more of joining the Cryoport group with its objective of making medical innovation achievable and more reliable for the benefit of patients around the world. It is a source of great pride and a huge motivating factor. The time was right for us to be part of an industry-leading organization such as Cryoport in order to support our business, expand our product solutions, and become a significantly larger player in the life sciences industry. We are excited to be part of Cryoport's strategic platform in the advanced therapies space in EMEA and look forward to continuing to lead Cell&Co as an integral part of Cryoport as it builds out its Global Supply Chain Network and other services."
SA Article, another Bullish Analysis
https://seekingalpha.com/article/4501644-cryoport-industry-leader-basking-tailwinds
The conclusion:
In all, I maintain my buy recommendation on Cryoport with a five out of five stars rating. As you can appreciate, it's rare to find a growth company that leverages the M/A model, which is also an industry leader like Cryoport. Being the logistics provider for the growing cell/gene therapy innovators, Cryoport is basking in the industry tailwinds. Both organic and M/A revenues are growing and leaping aggressively. Concurrently, the company is building and expanding its infrastructures to support future growth. During this bear market, you have another chance to pick that same great company at a fraction of its intrinsic value. The management realized that their shares are trading at a bargain. As such, they are buying back shares.
Thanks pfelgueiras, Great video, it sums up in a nutshell the company's outlook (yeah, I know) for approval.
Best of luck with your investments!
SA Article
https://seekingalpha.com/article/4499176-cryoport-risky-investment-upside-potential
A few charts comparing PPS with net income, revenue, debt, total assets...
Best of luck with your investments!
Wong board. Sorry about that post on this board. Moderators, please remove Post 468, on the other company.
SA Article
https://seekingalpha.com/article/4499176-cryoport-risky-investment-upside-potential
A few charts comparing PPS with net income, revenue, debt, total assets...
Best of luck with your investments!
BLA SUBMITTED!!! LYTENAVA™ is brand name
https://ir.outlooktherapeutics.com/news-releases/news-release-details/outlook-therapeutics-submits-biologics-license-application-us
They did keep their timeline. The PR is what was expected:
ISELIN, N.J., March 31, 2022 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company working to develop and launch the first FDA-approved ophthalmic formulation of bevacizumab for use in retinal indications, today announced it has submitted its Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for ONS-5010, an investigational therapy which, if approved, will be branded as LYTENAVA™ (bevacizumab-vikg), for the treatment of wet age-related macular degeneration (wet AMD). If approved, LYTENAVA™ (bevacizumab-vikg) could replace the current practice of using unapproved repackaged IV bevacizumab sourced from compounding pharmacies for the treatment of wet AMD.
“This BLA submission for our investigational ONS-5010 not only marks a very significant moment for Outlook Therapeutics, but represents a real step forward for potentially providing an on-label, FDA-approved alternative for the most frequently used anti-VEGF treatment in wet AMD patients in the United States,” said Russ Trenary, President and Chief Executive Officer, Outlook Therapeutics. “If approved for marketing, we hope to see our ophthalmic bevacizumab become a valuable on-label therapy offering clinicians and their patients a safe and effective ophthalmic formulation of a treatment whose value has been proven over many years of clinical practice. We are excited for the potential to offer an ophthalmic bevacizumab formulation that ships straight from our factory partners to distribution centers while avoiding the risks of using unapproved repackaged IV bevacizumab that is approved for intravenous use but not for intravitreal administration.”
In anticipation of potential FDA marketing approval in late 2022 or early 2023, Outlook Therapeutics has begun commercial launch planning, including best-in-class partnerships with FUJIFILM Diosynth Biotechnologies for drug substance, and with drug product manufacturer Aji Biopharma Services for finished drug product. The Company also is actively building out its distribution and commercial team structures.
“The significant efficacy results we are submitting from our NORSE TWO Phase 3 pivotal trial demonstrated the one-, two- and three-line visual acuity responders one would hope for in a pivotal wet AMD trial,” according to Terry Dagnon, Chief Operations Officer with Outlook Therapeutics. “Additionally, given the need to address the potential public health concerns related to repackaged IV bevacizumab, we are submitting the important integrated safety data from our NORSE registration clinical program. While noting reported ocular inflammation safety data from other recent product development efforts in wet AMD, we are very excited to be submitting our safety dossier. We observed a total of one ocular inflammation adverse event (iritis) reported from our three completed NORSE clinical studies. When normalizing this single event to the large number of ONS-5010 injections in our clinical trials, it occurred at a 0.05% incidence.”
“The retina community is very excited about a potential on-label treatment option of bevacizumab and the data we have seen from Outlook Therapeutics makes this a real treatment option for us upon FDA approval,” said Firas M. Rahhal, MD, Retina-Vitreous Associates Medical Group, Assoc. Clinical Professor of Ophthalmology, UCLA School of Medicine.
About the NORSE Registration Clinical Program for Wet AMD
The BLA submission is based on the totality of data from Outlook Therapeutics’ wet AMD clinical program for ONS-5010, which consists of three completed registration clinical trials: NORSE ONE, NORSE TWO and NORSE THREE.
NORSE ONE was a clinical experience trial involving 61 wet AMD participants at nine trial sites in Australia. It compared ONS-5010 to ranibizumab (LUCENTIS®) as a treatment for wet AMD. NORSE ONE showed the first markers of efficacy and safety in humans for ONS-5010 ophthalmic bevacizumab. In the trial, ONS-5010 efficacy and safety data were consistent with historical published studies of bevacizumab in ophthalmology. NORSE ONE also supported the trial design and inclusion criteria established for NORSE TWO, the pivotal Phase 3 registration clinical trial.
The NORSE TWO Phase 3 pivotal trial enrolled a total of 228 wet AMD patients at 39 clinical trial sites in the United States. It was a superiority trial design comparing the safety and efficacy of ONS-5010 ophthalmic bevacizumab dosed monthly against ranibizumab (LUCENTIS®) dosed according to the PIER dosing regimen in the LUCENTIS® label. The trial data met both their primary and secondary endpoints with high statistical significance and clinical relevance. For its primary endpoint, 41.7% (p = 0.0052) of patients gained at least 15 letters of vision, and for its secondary endpoints 56.5% (p = 0.0016) of subjects gained ≥ 10 letters of vision and 68.5% (p = 0.0116) gained at least 5 letters. The key secondary endpoint was also met: mean change in BCVA from baseline to Month 11, which was 11.2 letters gained (p = 0.0043). The NORSE TWO data also showed a strong safety profile consistent with previously reported data for ONS-5010 and prior research.
NORSE THREE was an open-label safety study of ONS-5010 in 197 patients conducted in the United States to provide the necessary number of retina patients dosed with ONS-5010 to complete the requirements of the BLA.
Safety results across the three NORSE trials demonstrated a strong benefit-to-risk safety profile. Across all three ONS-5010 registration trials, there was only one ocular inflammation adverse event, which was reported in NORSE TWO; the event was treated topically and resolved without sequelae. The most common adverse reaction (≥ 5%) reported in patients receiving ONS-5010 was conjunctival hemorrhage related to the injection procedure (5%). These safety findings continue to support minimal ocular inflammation and safety signals consistent with what was previously reported in the 2011 CATT trial (National Eye Institute) and other large adequate and well-controlled ophthalmic studies of bevacizumab.
New Prague facility returns to full production after fire
Q1 took a hit. CYRX says it's contained to Q1. Let's hope so.
Cryoport previously announced it would resume production at the New Prague facility during the week of February 14th and ramp up to full production during the first quarter of 2022.
The Company also guided to a revenue impact from the fire of $4 to $5 million limited to the first quarter of 2022. Production did resume as planned; however, a number of unexpected challenges resulting from the fire caused the recommissioning and validation of production to progress more slowly than had been previously anticipated.
As a result, Cryoport now expects a revenue impact from the fire of $9.0 to $9.5 million which will remain limited to the first quarter. As previously announced, the Company expects its insurance to cover the majority of the costs to restore and re-open the facility, as well as related business interruption losses. Management will concentrate on reducing shipment timelines to customers throughout the remainder of the year.
Gap up followed by a nice 9% move today (3/29/2022) thus far
I don't see news yet as to the reason behind it. The volume is below average (session is not closed yet), maybe just correcting after a very long down ramp (unjustified in my view, but that's the market).
I may be getting a bonus end of H1. If the PPS is still depressed, I might put back some money into CYRX. (I'm playing with house money for now after taking some nice benefit).
Best of luck with your investments!