Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Catalent, Inc.
"One of the facilities that experienced productivity issues is the Company’s gene therapy manufacturing site located in Harmans, Maryland near the BWI airport (“BWI”), where the Company’s plans to increase capacity for a customer’s product during the third quarter in order to ramp production was slower than expected. During this ramp-up, certain operational challenges, including those related to the initial deployment of a new enterprise resource planning (ERP) system at BWI, significantly reduced the expected revenue in the third fiscal quarter associated with the site, and will also impact revenue previously expected in the fourth quarter...
None of these issues is expected to adversely impact the quality or commercial launch quantities of any product made at BWI in light of, among other things, the level of “bright stock” on hand. However, revenue from the unproduced batches cannot be made up for in this fiscal year due to manufacturing capacity constraints. The Company expects to recover related revenue in the second half of calendar year 2023 (the first half of the Company’s 2024 fiscal year).
In the third fiscal quarter, the Company also experienced productivity challenges and higher-than-expected costs at its drug product and drug substance manufacturing facilities located in Bloomington, Indiana and Brussels, Belgium, where the Company was unable to achieve anticipated productivity levels and associated revenue due in part to the continued need to implement enhancements to its operational and engineering controls following regulatory inspections that occurred earlier in the fiscal year. While these issues are also expected to affect the Company’s fiscal fourth quarter to end on June 30, 2023, productivity levels in Bloomington are expected to be restored to previously forecast levels in that quarter. As with BWI, the Company does not expect to make up for the lost production at Bloomington until after the close of the current fiscal year.
After conducting an internal review of the Company’s manufacturing operations, the Company has taken a number of measures at BWI, Bloomington, and Brussels, including both management and operational changes, to address the root causes of the issues identified at each..."
All of this should be good for CDMO.
what about Thermofisher or Novo Nordisk, they can't make enough Wegovy at $350 a vial.
I remember
I want to remind people we closed at 14.59 on 1/29/2021 and 11.86 on 12/31/2020.
I'll take it
don't you mean over the $1B mark?
precedent not president. I guess you had the current politics on your mind.
mine's 25 and I am not that hopeful
David Carbone mentioned in the Columbus Dispatch today. Using a $3 million Pelotonia grant researcheers at OSU wil conduct a statewide research study
that will genetically test
more than 2,000 advanced
lung-cancer patients in an
effort to treat their illness
with targeted therapy.
The three-year Beating
Lung Cancer in Ohio initiative,
to begin in March,
will recruit patients newly
diagnosed with Stage 4 nonsmall-
cell lung cancer. They
will receive free testing for
300 genes, while also being
tested for a PD-L1 marker
used to help select certain
immunotherapy treatments.It often is
diagnosed in a metastatic,
or fourth, advanced state,
said Dr. David Carbone, one
of the lead researchers on
the study and director of the
Thoracic Cancer Center at
The James.
“Getting patients on the
right treatment — the first
time — is absolutely critical,”
Carbone said in a statement.
“We know advanced
genomic testing can help
us identify the patients
most likely to benefit from
a targeted therapy, which
is oftentimes a pill and
well-tolerated, vs. traditional
chemotherapies not
specifically targeted to that
patient’s genetic mutations.
...but despite a butt load of funding, numerous PR about "breakthroughs" and near earth shattering supposed "biomarker discoveries" etc...LITTLE has actually translated yet into any meaningful new cancer treatments and/or FDA approved products.
Data Supporting FDA Accelerated Approval in Advanced NSCLC
The accelerated FDA approval was based on a multicenter, open-label multi-cohort, activity-estimating study (KEYNOTE-001), which evaluated KEYTRUDA in a cohort of 280 patients with metastatic NSCLC that had progressed following platinum-containing chemotherapy, and if appropriate, targeted therapy for EGFR (epidermal growth factor receptor) or ALK (anaplastic lymphoma kinase) mutations and any evidence of PD-L1 expression by a clinical trial immunohistochemistry assay. A prospectively defined subgroup was retrospectively analyzed to evaluate PD-L1 as a biomarker among 61 patients with a PD-L1 TPS greater than or equal to 50 percent...
Approval of PD-L1 Companion Diagnostic for Patients with Advanced NSCLC
In parallel with the approval of KEYTRUDA, the FDA has also given Pre-Market Approval (PMA) to the first predictive companion diagnostic for use in detecting PD-L1, an immune-related biomarker expressed on some tumor cells: the PD-L1 IHC 22C3 pharmDx kit made by Dako North America, Inc., an Agilent Technologies Company. The data supporting the approval of KEYTRUDA for metastatic NSCLC showed that 22 percent of patients (n=61/280) had a PD-L1 TPS greater than or equal to 50 percent...
I had asked John Columbia with Alexander Capital about how the trial was designed and he said this.
The trial is powered to show a 2.1 month improvement in PFS over a control arm estimate of 3.5 months PFS.
For the current evaluation, the study did not show a significant difference between aldoxorubicin and investigator's choice therapy for PFS, with a median of 4.17 months and 4.04 months, respectively, for the study's primary endpoint (hazard ratio: 0.91).
Here's an example of a drug that failed in its first phase 3 trial and went on to get approved to treat several cancer indications. Oh yeah, it also has about 60 billion in sales.
Published: September 10, 2002
The biotechnology company Genentech said late yesterday that an experimental cancer drug that tried to block the flow of blood to tumors had failed its first late-stage clinical trial -- a blow to the company and to what had been considered a promising approach to treating cancer.
The company said that a Phase III trial of the drug, Avastin, did not meet its goal of extending by 50 percent the time before tumors worsened in patients with advanced breast cancer. The drug did shrink tumors, the company said, but that did not delay the worsening of the cancer or improve the odds of surviving for one year.
The failure deals a significant blow to Genentech because Avastin was considered one of its big potential new drugs. A successful trial might have allowed the company to apply for regulatory approval...
Cover of time magazine: Inside the brutally selective, hugely expensive, life saving trials of immunotherapy
http://time.com/4270414/in-the-latest-issue-64/
Does anyone know how quickly these people look at events, once a week? once a month?
I wish we never visit the 1.20s again.
In the movie The Constant Gardener the bad chemical company was Peregrine also. And of course there is Peregrine Financial. People like the falcon.
Can you fix your date to 2015. I think June 2014 is over.
Well it made it to Cleveland now.
If you are going to the ASM are to going to reveal your identity?
At this point it seems clear ....no partner until trial results. With two failed trials and one botched pphm needs to prove bavi works to a partner.
There is an issue with the high compensation but that didn't outweigh the other factors that I considered for this investment. It's not going to change and in the long run it's a non-factor.
If you want an investment without any issues you should consider buying treasury bonds.
Number one, there's nothing criminal going on here. Number two, they aren't sucking money out, they're funding operations. Yes, as a result they're diluting all shareholders. The thing is, management has warned us that dilution could happen so anyone buying shares is taking on that risk. There's a section in every 10K and 10Q that's titled "THE SALE OF SUBSTANTIAL SHARES OF OUR COMMON STOCK MAY DEPRESS OUR STOCK PRICE." that warns investors about this. The latest 10K goes on to say "In addition, we will need to raise substantial additional capital in the future to fund our operations, including our Phase III SUNRISE trial. If we raise additional funds by issuing equity securities, the market price of our securities may decline and our existing stockholders may experience significant dilution.". Don't blame management for this situation. If anything, blame yourself for buying shares and ignoring the obvious pitfalls.
PPHm is down about 50% from their announcement over 5 years ago.
Based on my research, I'm long PPHM. Based on your research, you're obviously short PPHM. That's fine with me but at the same time I'm not going to wish you luck with your investment. IMO, the world will be better off if PPHM and Bavi are successful.
Personally (as in PERSONALLY) I think we will have some news in September (Liver in Kyoto) but I do not think we'll have the partner news before the end of the FY vs calendar year (I am STRICKLY limiting to 2nd ln NSCLC). I think any partner there will at least want to see PIII preliminary information given the financial conditions and terms PPHM will ask for.
PPHMVERYLONG, help me out here. I really can't agree with anything you said in this post. Maybe you can clear up some of these issues I have.
The reason they have been so silent is nothing is pending. You know the people on this board realize that when they keep talking about full enrollment and 2016.
The street wants a partnership or full Phase II results at a minimum. Neither will happen in 2014.
...think of Cotara- hundreds of millions spent and they cannot give it away
Bavi has failed in all Phase II trials but one and "the botched" one is not taken seriously.
If they really were impressed, they would have given it BTD but they did not and will not.
Since you take all of these predictions and forecasts to heart and then they ultimately go up in smoke resulting in a great deal of frustration to you, I have a suggestion that could help you out. Just sit tight with your investment in PPHM but stop reading this message board and ignore anything that management says.
You deserve a life without these burdens. Good luck with your new brighter future and I'm looking forward to hearing from you again when the share price is above 10 dollars.
My guess we see a partnership after an interim look at Phase III data if the data looks good as we think it will.
You were too quick on that one.
What is the number we make it to 500 M market cap? And when do people stop calling this a penny stock?
It was hard to get any work done yesterday while watching the stock market.
40.8 percent will get cancer in their lifetime. About 2 out of 3 survive for 5 years at the present time. May Bavi help people to live longer healthier lives.
PPHM closed Sept 6, 2012 at 3.07 and opened Sept 7,2012 at 3.15. The high that day was 5.08 and close was 4.50 for a gain of 46%. The high of the day was a gain of 65% over the previous close. I hope this keeps filling that gap to 5.39 and beyond. Glta Pat on the back to my old man today.
High of 2013 was 2/13/2013 2.43. Great day today.
The math is fine. The share count three years ago was 67.8 million.
BTW, selling the company for 1 Billion 3 years ago would have been $20 a share.
That means just to get to the same point now it would have to sell for about $75 just to get the same value while you lost all that interest.
It then took the mangling on the annual to 'non-officially', rumour grade, find out that there seemed to be/could be a second interim look-in. However, this piece of information was only confirmed to a very small group of people through information send out in offerings for the preferred shares by MLV, listing it as a reason why one should subscribe to the preferred shares.
When you do that, we feel that it's possibly, even a little bit overpowered, and so, as a result, we have built in, again, this is pretty standard, a couple of interim looks, so that if early on, your magnitude of effect is really good, then you can maybe take advantage of that during the interim analysis.
Facilitating the Development of Immunotherapies:
Intermediate Endpoints for Immune Checkpoint Modulators
3. "Milestone" Survival Analysis
In this approach, the proportion of survivors based on the Kaplan-Meier estimate at an interim time point is assessed in a fully powered study, and the probability of survival at the interim point is used as the basis for accelerated approval, with the confirmatory endpoint being final log-rank analysis of overall survival at a later time point in the same trial when the pre-specified number of events is reached. To support this proposal, a retrospective analysis of a phase 3 ipilimumab trial was performed (CA184-024; ipilimumab + dacarbazine vs. dacarbazine alone). This trial enrolled 502 patients with advanced but previously untreated melanoma and demonstrated an overall survival benefit for the ipilimumab combination arm (9.1 vs 11.2 months; HR = 0.716; p-value = 0.0009) (30). To assess "milestone" survival, Kaplan-Meier probability analysis was conducted for the first 300 patients randomized into the trial once those patients had reached a minimum of 2 years of follow-up. The analysis showed that the estimated 2-year overall survival rates among these 300 patients were 14.1% and 24.9% (p-value = 0.021). The timing of the analysis could have been accelerated by a year if this analysis had been incorporated in the original study design.
In addition to potentially serving as a surrogate endpoint for accelerated approval, this milestone analysis approach has several other advantages: it provides greater statistical power to detect a treatment benefit at an interim analysis, it would enable information regarding survival probabilities and long term survival information to be included in the package insert, it entails a predictable timing of analysis, and KM probability is also an OS endpoint...
Why is that troubling?
You are asuming that all the preferred shares are going to be sold immediately. I don't think so.
I already addressed those frustrations of yours in my post 156989. So again, why don't I ever see you post anything positive on the up days?