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Thanks sukus, great find. I saw pictures of Ned at the Inaugural Glioblastoma Awareness Day Reception but I didn’t know that he gave that speech. So now we know how the Acting FDA Commissioner really feels about GBM. According to him, “No other cancer pisses me off more than GBM.” Hmmm, yes it is very interesting.
http://www.sujuanba.org/blog/fighting-cancer-in-celebration-of-the-inaugural-glioblastoma-awareness-day
No comments here about the Mako report today?
Have to say he makes a pretty case, but I could debate a few points. He certainly did time it well!
This board really is dead, and I guess most posters have moved on. CYRX has had a pretty good run but it has been pretty volatile, and there is money to be made from that too.
Underestimate Linda Powers at your own peril. This is personal for her, as it is with many of those associated with Northwest Bio, who have all lost loved ones to cancer. She has been entrusted to see that the esteemed Dr. Liau’s elegant creation receives the recognition it deserves, and becomes part of the new standard of care for not only the treatment of GBM, but many other cancers. Linda is well aware that there are thousands of cancer patients who are literally dying to be treated with DCVax and who are depending on her to get this treatment to market. History is littered with hundreds of failed trials in GBM, and the odds of success are next to impossible. She has met and overcome every challenge to date, and has done everything possible to keep the lights on, and the trial going, until the final results, and full potential of this treatment can be understood and presented. In the face of overwhelming odds, and relentless attacks, many people would have caved under this pressure, but not Linda. She has persevered, and this has likely only hardened her resolve and determination.
There has been a lot of management bashing on this board, and some of it may be justified. No, they haven’t been perfect. But walk a mile in their shoes, and then you can speak. Many of these message-board pundits have been calling tor the unblinding of this trial for years, but yet, Linda waited. In an underpowered study, this wait allowed all the data on all the patients to be collected, improving the odds of success. It also allowed time for the regulatory authorities to write new rules for cell and gene therapies and create more paths for approval, and it allowed long-term survival data to develop for insurance coverage.
This is the most critical time for this trial, and Linda and Northwest Bio have been through too much and have too much riding on the results to allow success to be taken from them at this time, and she is doing everything possible to ensure that mistakes are not made, and that the data is analyze and presented in a way that maximizes the potential for success. I can’t ask for much more than that.
Forgive me for butting in Umibe, but I beg to differ.
Perhaps what you say is true under previous administrations. May I ask if you have worked with the regulatory agencies in the U.S. under the current administration? It seems to me that most of them are now headed by former industry lobbyists who seem much more interested in loosening regulations. This may be a good thing in the case of the FDA In particular. I’m sure that you’ve noticed the recent change in direction by the FDA under former Commissioner Gottlieb with their efforts to speed up drug development and the issuance of new guidelines for surrogate endpoints, qualifying biomarkers, real-world evidence, patient reported outcomes, to name a few. Remember this speech by Gottlieb https://www.fda.gov/news-events/speeches-fda-officials/remarks-national-comprehensive-cancer-network-policy-summit-06252018
“What should we do, for example, guided both by ethics and science, when a new drug in a heavily pre-treated group of terminal cancer patients, is in a Phase 1 study where it shows a dramatic response in more than half of these patients? . . . And how we randomize patients to such a treatment?. . .
One is the use of seamless drug development programs, where drug developers can plan to quickly expand enriched Phase 1 cohorts, and evaluate the drug in one continuous clinical trial. This leapfrogs the traditional sequential three phases of clinical trials. It eliminates all of the time spent starting and stopping drug development in between each of those different stages.
We didn’t evolve our approach overnight. And we didn’t evolve on a whim. We followed the science.
And we followed the growing refrain from the broader clinical community, and especially from patients, who themselves compelled us to chart a new course because of the way that this science is bringing with it new opportunities to extend life.
Let me take a moment to reflect on those opportunities that we’re seeing, and take measure of what’s been realized on behalf of patients. Enriched trials can more easily demonstrate a robust impact on intermediate clinical endpoints or surrogate endpoints that are likely to correlate with long-term clinical outcomes. Effects like tumor shrinkage or progression free survival can translate into the ability of patients to stay off more toxic regimens for a longer stretch of time, therefore improving their quality of life. These observed effects may challenge our ability to achieve clinical trial equipoise, which is the doubt about whether new therapy may be more effective than the existing standard of care. This is especially true when there are few or no effective treatment alternatives.
Under these circumstances, where we know a drug can produce a robust response in a tumor that’s otherwise hard to treat, we may not be able to ethically randomize patients. Pivotal trials testing these products are also likely to have crossover designs, meaning that if a patient’s cancer grows on the comparator treatment, then the patient is switched over to the experimental arm. Both arms receive the experimental drug, although in different sequence. Statistically, this may make it difficult to show an overall survival advantage for the experimental arm. Patients aren’t left on the comparator arm for long enough to show that they would have died sooner if left off the new drug. There’s a simple bottom line here. When new drug shows a robust effect on things like tumor size or tumor progression, patients are understandably less willing to forgo a new therapy in the name of a good “p” value."
It almost sounds like he’s talking about Northwest Biotherapeutics doesn’t it?
Simply based on the information arm patients and the blinded data presented to date, it is clear that Northwest will provide some very compelling evidence of efficacy and long-term survival when the final data is analyzed and presented, This evidence will not only include extremely long-term data for those patients admitted into the trial, but it will likely also include information on all the treated patients that were excluded from the trial like the 32 with rapid progression, the 55 in the information arm, the approximately 100 EAP patients, and possibly patients like Brad Silver, Kat, Kristyn Power Sara Rigby, Alice and others. All this evidence may or may not be included in the BLA submission, but based upon the new guidelines and more flexibility of the FDA and other RA’s, I think it’s likely they will want to evaluate the totality of evidence in making their decision. I find it extremely difficult to believe that based upon this large body of evidence of extended survival (the gold standard) and the extremely benign safety profile of DCVax, for one of the most deadly of cancers, with no other viable treatment options, that regulators won’t find a way to approve it.
But if they did? Oh, there would most definitely be a HUGE outcry from the patient advocacy groups. They, along with many neuro-oncologists and their patients have been waiting a VERY long time for this.
Hey mike, I’ll agree that it was a good quarter. Anything stand out to you?
It was especially good news for Yescarta and Kymriah, (and therefore Cryoport) that CMS (Medicare) agreed to cover CAR-T therapies. The market seemed to like it too.
Cryoport a core holding? In my opinion, CYRX should NOT be the main part of a portfolio, and should only be a small portion of a prudent investor’s diversified portfolio. It has been pretty volatile these past couple of years. I haven’t updated my model lately but it’s showing around $35M in revenues this year and I think around $50M next year, and yet CYRX sports over a 800M market cap. So yes, revenues are growing nicely, but the valuation is becoming a bit stretched to put it mildly. (Hate to agree with CN, but I have to ; ) ) But I know you’ve been in it for a long time, and obviously have a high risk tolerance and a very long time horizon, so I think you’ll be alright.
Thanks ex. I couldn’t recall who suggested it, but for some reason I thought it was JerryCampbell.
No, certainly nothing nefarious. Just another day at the office, crushing the fortunes of retail investors.
Doc, This little nugget from the recent 10-q might be a clue that the time is near.
The Board approved a 5.5 million option pool to various external manufacturing parties (Advent BioServices, the Royal Free Hospital, Fraunhofer and other consultants) in December 2018. We have not allocated the options to the individual manufacturing parties but anticipate doing so during the latter half of 2019.
On August 1, 2019, the Company issued 640,000 shares of common stock at fair value of $141,000 to an external consultant for services provided to research and development.
Muddy Waters’ Block says Neil Woodford-connected companies are targeted by short sellers
By Steve Goldstein Published: Aug 8, 2019
https://www.marketwatch.com/story/muddy-waters-block-says-neil-woodford-connected-companies-are-targeted-by-short-sellers-2019-08-08?link=MW_latest_news
The holdings of embattled U.K. fund manager Neil Woodford are being targeted by short sellers, the head of Muddy Waters Research said Thursday after disclosing a short position that drove the company’s market value down by over half.
Carson Block, the founder of Muddy Waters, was interviewed on the BBC’s Today program about his decision to go after Burford Capital UK:BUR+11.84% a litigation finance firm.
“Well, for your listeners who might not know this, I’ll let them in on a secret—short sellers do definitely look for where Neil Woodford is invested, especially when he’s invested outside of large-cap value,” Block said. “He’s got a great track record in large-cap value, he does not have a great track record in life science and some of these smaller-cap stocks. “So there’s always the temptation to go looking at where he’s been invested,” Block said.
Hmmmm . . . it appears that someone on this board knew about this, and it could explain some of the recent selling pressure in NWBO.
The market will sort it out in due time. And it certainly doesn’t take a quant to figure out that angle.
Ah ha. That makes sense Doc. Thanks for the reply. I hadn’t considered the “optimized version” aspect. And yes, I remember another CEO discussing partnering one of their company’s pipeline cancer drugs, and he remarked that he expected negotiations to take over a year. LP certainly understands what she has, the value of it, and the implications for the industry. Hopefully soon, everyone else will understand it as well.
Sos has a new article out today . . .
Antares: Highlights from 2Q, 2019 Conference Call (ATRS, $3.29, Buy)
https://smithonstocks.com/antares-highlights-from-2q-2019-conference-call-atrs-3-29-buy/
And the games continue . . . unbelievable!
Pending Litigation
From time to time, the Company may be involved in various legal matters generally incidental to its business. Although the results of litigation and claims cannot be predicted with certainty, after discussion with legal counsel, management is not aware of any matters for which the likelihood of a loss is probable and reasonably estimable and which could have a material impact on its consolidated financial condition, liquidity, or results of operations.
On October 23, 2017, Randy Smith filed a complaint in the District of New Jersey, captioned Randy Smith, Individually and on Behalf of All Others Similarly Situated v. Antares Pharma, Inc., Robert F. Apple and Fred M. Powell (“ Smith ”), Case No. 3:17-cv-08945-MAS-DEA, on behalf of a putative class of persons who purchased or otherwise acquired Antares securities between December 21, 2016 and October 12, 2017, inclusive, asserting claims for purported violations of Sections 10(b) and 20(a) of the Securities Exchange Act of 1934, as amended, against Antares, Robert F. Apple and Fred M. Powell. The Smith complaint contends that defendants made false and/or misleading statements and/or failed to disclose that: (i) Antares had provided insufficient data to the FDA in connection with the NDA for XYOSTED ® ; and (ii) accordingly, Antares had overstated the approval prospects for XYOSTED ® . On July 27, 2018, the court entered an order appointing Serghei Lungu as lead plaintiff, Pomerantz LLP as lead counsel, and Lite DePalma Greenberg, LLC as liaison counsel for plaintiff. On August 3, 2018, the parties submitted a stipulation and proposed order, setting forth an agreed-upon schedule for responding to the complaint, which the court granted. Pursuant to that order, plaintiff filed a Consolidated Amended Class Action Complaint on October 9, 2018. On November 26, 2018, defendants filed a motion to dismiss. Plaintiff filed an opposition to the motion on January 10, 2019 and defendants filed a reply in support of their motion on February 25, 2019. On July 2, 2019, the court dismissed the complaint in its entirety without prejudice. On July 29, 2019, plaintiff filed a Consolidated Second Amended Class Action Complaint against the same parties alleging substantially similar claims. The Company believes that the claims in the Smith action lack merit and intends to defend them vigorously.
You’re right - good catch.
Okay, let the upgrades begin . . . Err scratch that. Let the reiterations begin!
In a report released today, Oren Livnat from H.C. Wainwright reiterated a Buy rating on Antares Pharma (ATRS), with a price target of $4.50. (same PT he's had since last October)
Looks like someone got caught with their pants down. First post and that was it?
Yep without the Ferring payment, the number would have been about $26M. It was a very good quarter and conference call, and it looks like Antares has finally turned the corner. They are nearly cash-flow positive, and are.almost covering their sales expense for Xyosted in the first six months!
My model only took a couple hours and is very crude. Some cells only have numbers and no formulas right now until I do some more work. For the first time, Antares is starting to break out individual product sales like Otrexup and Xyosted which is helpful. For Antares’ model, it’s all about the sales. And by the way, the numbers Simon’s getting for his spreadsheet are very accurate, which is good to know. Unfortunately, Antares’ partnered products are a little more difficult to track and forecast without knowing the exact percentages. Hope Teva can get its act together, and I will be interested to hear what they have to say on their call.
ou, thanks for your work on the spreadsheet. It’s been very helpful.
I think most people familiar with new drug launches would say that the Xyosted launch is going very well so far, and probably better than many expected. I don’t worry about the weekly prescription slowdown. It’s still very early, and prescription data early in a new launch tend to be lumpy week to week, so the four week moving average is a better way to see the trend, and so far, it’s still positive.
Competition from the pills is going to happen at some point. Lipocine has been denied both times they applied for approval, and the most recent CRL listed numerous deficiencies, so approval in November is far from certain. (I’d say odds are 50/50) Even if their NDA gets approved, Tlando has to be taken two or three times a day with a 800-1000 calorie intake. There are potential patient compliance issues, and many physicians may be reluctant to even prescribe this for some patients. In addition, Lipocine is a tiny clinical-stage company with no marketing or commercial infrastructure, or experience navigating formulary and insurance hurdles encountered when launching a new drug, so unless they find a good partner, they may have a very slow launch.
Interesting report at Zacks on LPCN. A recent study demonstrated a link between non-alcoholic steatohepatitis (NASH) and low free testosterone. As the disease progresses, the hormone levels decline. This mean that there may be a MUCH larger market for Xyosted.
I don’t want to repost too much of the report here but it’s worth a read. He also had this to say as it relates to Antares:
“As Lipocine advances its newest candidate, it appears that the environment for TRT is also moving in the right direction. In May, TLANDO received a November 9, 2019 Prescription Drug User Fee Act (PDUFA) goal date, as provided by the FDA. This was preceded by two other TRT therapy approvals including Antares Pharma’s injectable testosterone enanthate, branded Xyosted. Xyosted was approved in October 2019 and was launched in November 2018.
Antares’ new and experienced sales team combined with a strong marketing push and less competitive pressure from previous generations of testosterone has created the setting for a strong launch. As generic options have emerged in the gels, restrictive contracts with payors appear to be fading. Xyosted sales of $70,000 in the month of December, grew to almost $2 million in the month of May. Weekly total prescriptions exited 2018 at 26 rising to 980 by the last week of June 20196. The 26% growth in weekly prescriptions from May to June suggests a similar increase in month over month sales. This strong performance out of the gate points to a favorable environment for new and improved testosterone therapies. We think Lipocine’s oral option is the most convenient for patients compared to injection, patches or gels. If approved, a fixed dose oral option would be easy to use for patients as it would not require additional dose adjustments or related doctor visits. It should also be less confusing for prescribers as it is not prone to titration decision errors and predictable from a cost perspective for payors relative to products that need significant up-titration in dose.”
https://scr.zacks.com/News/Press-Releases/Press-Release-Details/2019/LPCN-Poster-Demonstrates-NASH-and-Free-T-Link/default.aspx
Yep, I have the script spreadsheet bookmarked, and it has been very helpful. I’d agree that the market is skeptical, but I will also add that many of these small bios are “controlled” by the hedgies, and their playbook is to short the launch of a new drug on the approval pop. With the insurance hurdles now blocking initial access, the odds are certainly in their favor. Antares really didn’t help themselves either by having the smallest cash reservers for a drug launch that I think I’ve ever seen, and they basically had to thread the needle. Not many, besides us dumb retail, would have thought they could actually pull it off with such a minuscule salesforce, and so little cash. And yet, it’s beginning to look like they just might. It’s still early, and ATRS is in the “prove it” phase, but I think after another couple quarters this will pass.
I also agree with you that securing the debt financing was critical, yuge, and it probably caused the naysayers some pause. I really believe that Xyo could grab a much larger share of the market even faster with the proper marketing budget (incl tv ads) next year, but really can’t argue against their strategy of keeping their costs controlled and reaching profitability. I still have my concerns with Teva and their “pay for delay,” and other shenanigans, but I’m still optimistic for gen Epi and gen Forteo. Getting that AB rating and rapid insurance coverage will also be critical. So yeah, the next six months will be pretty telling, and if things continue to break the right way for Antares, I think you’re right, and we could see a double or triple next year.
Hey CN, I guess you are still around. I’m also hopeful the 2nd quarter numbers will look good. Analysts are projecting anywhere from $20M - $24M, with consensus around $21M, and even Mr. bullish but conservative, SoS is estimating $20.5. So why do you think analyst’s estimates are so low? I guess they expect lower earnings due to Makena? If that’s true, I’m not really sure why because on the 1st quarter conference call in May, Antares management said that their device shipments for Makena were still solid, and at an investor conference in June, AMAG shared that Makena SC market share was increasing, and reaffirmed that sales are still on target. And yes, Makena IM is taking a big hit due to generic competition and supply issues, but I don’t think SC is having this problem. AMAG reports next week, and it should be quite interesting.
Anyway for Q2, my model estimates a slight growth in Makena sales, as well as very solid growth in both Xyo, and gen Epi, for a total of $27.4M. I actually think this estimate could even be a little low due to the inventory builds for the full launch of Epi and pre-launch of generic Forteo, but If I’m even close to correct, then we might see some more short-term buying pressure. I don’t expect management to raise their guidance until the 3rd quarter call in November, so the sheepish analysts probably won’t make their upward revisions until then, which is why I think the buying pressure will be short-lived. We may have to deal with the market games for a little while longer.
But I’d agree that ATRS is mostly de-risked except for Makena, which still has a (small) chance of being withdrawn from the market. Going forward though, by next year, it would have a much less significant impact when Xyo, Epi, and then Forteo take off.
BTW - You still in CYRX?
Hi flipper / senti
Just curious if you have read the correspondence between Novartis and the FDA with regard to Piqray, which received approval through the RTOR process? It appears to me that when Novartis met with the FDA for their pre-NDA meeting to discuss their submission on October 16th (after submitting their data and analysis, which confirmed the trial met its primary endpoint), at that time, Novartis was simply requesting “priority review.” It is unclear though who suggested using the RTOR process, it just says:
“Meeting Discussion: The FDA and the sponsor agreed to conduct the review using the Assessment Aid and the Real Time Oncology Review (RTOR) pilots. The FDA agreed to standing bi-weekly teleconferences with the sponsor, which can be canceled if there no issues requiring discussion. For the CMC section, a decision on standing teleconferences or an extended face to face meeting will be decided once the CMC section is received. If the sponsor has updates to the original submission, they will not replace the original documents, instead they will submit an updated document with tracked changes, summary of changes, and final version. FDA will base their review on the originally submitted documents unless instructed otherwise by the sponsor. The table above represents the agreed upon timeline for submission of components of the application. “
My observation just looking at the correspondence though, it appears that Novartis had a pretty straight-forward IND and NDA in a nice neat package that was ready-made for this type of approval process. (and Charlene Wheeler was involved throughout)
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212526Orig1s000AdminCorres.pdf
Should the FDA speed up or slow down approval of new cancer drugs?
By JASON SHAFRIN JUNE 21, 2019
https://www.statnews.com/2019/06/21/fda-new-cancer-drug-approvals-speed/
Earlier this month, the Food and Drug Administration announced the creation of Project Facilitate. This pilot program facilitates access to innovative treatments for cancer that have not yet been approved by individuals who aren’t able to enroll in clinical trials. This move suggests that the FDA finds the approval process for cancer drugs to be too slow.
At the same time, some experts want the FDA to slow down the approval process for cancer treatments. A recent article in JAMA Internal Medicine argued that cancer drugs are receiving accelerated approval without sufficient evidence proving they are safe and effective. More specifically, the article raised concerns over the widespread use of surrogate outcomes to measure treatment efficacy.
Surrogate outcomes, such as progression-free survival and treatment response rate, are imperfectly correlated with overall survival. The authors suggest that the FDA is approving cancer drugs too quickly, as these surrogate endpoints may not provide sufficient evidence of improved long-term survival.
Is the FDA correct in its approach? Research I have done with various colleagues argues that if you believe in patient-centered care, the FDA is indeed doing the right thing.
Taylor Schwartz, Tony Okoro, John Romley, and I looked at whether cancer patients and physicians had similar preferences regarding the risks of treatment. We surveyed patients with advanced melanoma and physicians who treat the disease, asking them to choose between two hypothetical cancer therapies: Therapy A provided certain survival of exactly four years, no more and no less. Therapy B had the same average survival as Therapy A, but was riskier. Specifically, half of individuals who received Therapy B lived for less than a year, but 1 in 5 lived for more than seven years.
While only 30% of physicians preferred the riskier Therapy B, 63% of melanoma patients preferred it. In fact, patients were willing to give up one year of certain survival on average in order to have a chance to get Therapy B.
We got similar results when we repeated this survey in patients with lung cancer and physicians who treat it.
The phenomenon that individuals with terminal illnesses prefer riskier therapies is known as the value of hope, something that has been confirmed in other studies. Cancer patients — or more generally people with terminal illnesses — have a strong preference for therapies that provide some chance of long-term, durable survival even if they are riskier.
While our study described patients’ preferences when the survival outcome is known, in most cases the odds of survival are uncertain because many clinical trials use surrogate endpoints. Other research I’ve conducted shows that many surrogate outcomes are often good — albeit imperfect — predictors of real-world survival.
In a study published in Value in Health, my colleagues and I used data from clinical trials and real-world evidence to determine how well surrogate endpoints predicted real-world overall survival. The study followed a three-step process. First we examined 21 trials that reported both a surrogate and an overall survival endpoint and looked at reported treatment effectiveness using both. Next we used real-world data to measure the effectiveness of these treatments on overall survival. Finally we measured the ratio of treatment efficacy assessed in the clinical trial with that measured using real-world survival data.
Our study found that treatments were 16% less effective in the real world than predicted in the trial based on surrogate endpoints. The percentage varied depending on tumor type, the number of patients enrolled in the clinical trial, line of therapy, and a number of other factors. Overall, we found that while a discount should be applied to evidence from clinical trials using surrogate endpoints, these endpoints are useful predictors of real-world effectiveness.
A final item to consider when weighing whether to speed up or slow down access to cancer treatments is the cost of delays. These costs occur along two dimensions: money and health.
The FDA could require longer clinical trials or additional confirmatory trials. These trials would clearly be useful for providing additional high-quality evidence, but doing so comes with additional financial costs. If clinical trial requirements become stricter, it is likely that drug manufacturers’ research and development costs will rise. In response, they may raise prices to offset higher R&D costs. Or, if prices are held constant, there is likely to be less innovation.
In addition to the monetary cost, any FDA push for more detailed evidence requirements would likely delay access to treatment and have an adverse impact on patient health. Research I conducted with other colleagues found that faster access to novel cancer therapies dramatically improves outcomes. Specifically, we found that cancer patients who lived in regions with the most rapid access to novel cancer therapies survived 10 months longer than individuals who lived in regions with the slowest access.
Thus, while increased evidence requirements may improve health outcomes by ensuring that cancer drugs are safe and effective, it’s important to consider that the delays they cause may cost lives if patients who need treatment can’t receive it.
The argument I’m making is not that we don’t need robust evidence on the safety and efficacy of cancer drugs. We do. Rather, when making decisions about the required level of evidence to approve cancer drugs, the FDA should continue taking a more patient-centered approach and weigh more carefully the costs of delayed access to novel cancer treatments.
Jason Shafrin, Ph.D., is the senior director of policy and economics at Precision Xtract, a consultancy to the pharmaceutical and life sciences industries, and the founder and editor of the Healthcare Economist blog.
I saw that too senti. I seriously doubt many oncologists even understand how the system was gamed to get this device approved, and have no other options to offer their patients, and simply recommend it because it has the FDA’s stamp. On one hand, it disgusts me that this device was even approved, but on the other hand, at least now the patients who qualify won’t have to spend their life savings in their final days for this false hope, like my grandfather did. DCVax-L approval can’t come fast enough in my opinion!
Thank you for this excellent post sentiment_stocks. These scenarios are exactly what I believe as well, but your thoughtful analysis is far more in-depth, and articulated masterfully. My thoughts continue to the corresponding level of insurance reimbursement, and stock price in each scenario, but I’m glad you left it where you did, as there’s more than enough speculation on this board already.
Thanks for the article Hbpainter. I liked this part:
“The findings provide clues as to why existing cancer treatments fail to stop glioblastoma growth. “If you understand that this is a disease with multiple states driving it, each one with a corresponding favorite cancer gene, you understand better why targeting one gene at a time has failed so far, and you can dissect the mechanisms of adaptation and resistance to therapies,” said Suvà.”
It reminded me of Linda Powers’ presentation at the Phacilitate Conference when she explained that “the approach taken by the Company’s DCVax therapies uses Nature’s system and is the opposite of a “silver bullet” approach: i.e., many active agents against many targets, rather than a single active against just one or a few tumor targets.”
And Ms. Powers also noted that, “in addition to Glioblastoma, other types of solid tumors also involve extensive variations and corresponding treatment challenges. To date, only limited numbers of patients (e.g., 5-30% for various cancers) have been reported to respond to immune therapies for solid tumors, including checkpoint inhibitors. In light of the extensive variation among solid tumors, a patient’s version of a cancer may or may not express a particular single target or couple of targets.”
In that presentation, she really set the stage for the next evolution in cancer treatment, i.e. the era of the DC cancer vaccine.
Thanks Doc. I get it.
Thanks flipper. It certainly wasn’t my intention to drag up yet another issue has been rehashed exhaustively like so many others on this board.
Thanks Doc. I have thought about it and I guess that’s what I’m concerned about. We know that the product has essentially been improved from what Fraunhofer said. And we know that Les has attempted to characterize this as an improvement in “manufacturing methods” rather than and improvement in “product.” My question was whether you had factual knowledge that the regulators were satisfied with Les' version that the manufacturing process changes hadn’t essentially changed the quality or efficacy of the product.
Doc,
You have repeated that phrase “art” so many times that you must believe that it is, or will become fact if you repeat it enough. Whether these process changes are considered an “improvement” or “art” is still open for interpretation by the regulatory authorities, particularly a change that allows the inclusion criteria to include patients with a lower white cell count. The regulatory authorities may still require additional equivalency studies to determine if the products are essentially the same. Do you know if these studies have been completed? Do you know that these changes were in fact pursued by regulators? Or are you just suggesting that?
To be clear skitahoe, Adam F is definitely NOT an analyst. He’s known as a columnist or journalist, but you can’t even call him that. He’s a hack.
And FYI:
hack - Dictionary Definition : Vocabulary.com
If you call someone a hack, you mean they're not great at what they do — especially writing. A mediocre writer is called a hack. Once upon a time hack was short for “an ordinary horse,” and now it's an insult for writers.
Under the terms of the convertible notes, if the stock price exceeds $17.48 for 15 consecutive trading days prior to Dec 2021, then the notes automatically convert into shares of common stock at $13 a share (as long as certain other provisions are met). I believe the 15th day above $17.48 occurred yesterday or possibly today. Like I said in my last post, I believe the stock is being supported. Seems pretty clear this is the reason.
This just sounds like they agreed to delay the conversion date a few weeks.
Yes a very high price was paid for less than $4M in revenues, but at least Cryogene was profitable, which is more than Cryoport can say. Nearly $11M in goodwill though? Ouch! It’s not like there was a bidding war. Unless they really needed the storage for some upcoming pending commercial approvals?
I also don’t recall an offering being priced so quickly after the initial announcement - literally a few hours. It’s clear they were concerned about a sell-off due to speculation of the pricing. Not so sure the “market is absorbing it pretty well” as you say. It looks like it may be supported right now. Will see how long it lasts.
Surprise Surprise - Cryoport Announces Proposed Public Offering of Common Stock
IRVINE, Calif., June 19, 2019 /PRNewswire/ -- Cryoport, Inc. (CYRX) (Nasdaq:CYRXW) ("Cryoport" or the "Company") today announced that it intends to offer shares of common stock in an underwritten public offering under an effective shelf registration statement on file with the Securities and Exchange Commission (the "SEC"). The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering. Cryoport also expects to grant the underwriters a 30-day option to purchase up to an additional 15% of the shares of common stock offered in the public offering. All of the shares in the offering are to be sold by Cryoport.
The public offering will be made pursuant to a registration statement on Form S-3 that was previously filed with and declared effective by the SEC. A preliminary prospectus supplement and accompanying base prospectus relating to and describing the terms of the offering have been filed with the SEC and are available on the SEC's website located at www.sec.gov or may be obtained from Jefferies, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, or by telephone at 877-821-7388 or by email at Prospectus_Department@Jefferies.com; or SVB Leerink, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, or by telephone at 800-808-7525, ext. 6132 or by email at syndicate@svbleerink.com. The final terms of the offering will be disclosed in a final prospectus supplement to be filed with the SEC.
Anyone not see this one coming? 3M @ $17? Any guesses?
Ha ha. Nope, don’t really gamble except a little sports wagering for fun. Don’t like to lose. To each his own, but didn’t you put a bunch on CYRX and their management many years ago? Learned your lesson huh?
I’ll just say this - things don’t always happen according to plan, and the loudest narrative isn’t always the correct one. I have a different take on management, and I’m pretty confident they will get it approved one way or another. But I don’t expect we will hear anything about it from Cryoport.
I think CYRX could still see higher highs before then so you might be alright. And if Northwest’s trial produces the favorable results we hope, it should be good news for Cryoport. And yep, I’m in over 500k shares.
Yes I did laser . . . on that day as a matter of fact. Didn’t like the way the overall market was setting up and i believe this one has gotten out over its skis again. You know, the old adage “sell in May and go away.” You still in it?
Well so far the market appears to like it, but it will be interesting to see the details on this transaction. I can only find limited information about this tiny, private company. Appears to be about 5-10 employees, and between $1-5M in sales. Some of their facilities appear to be modern, and others? Not so much. . . http://cryogenelab.com/pricing/
More commercial approvals would certainly help. And yes, initially a limited patient population, but another indication for Sickle Cell Disease could greatly increase the patient pool. I’m not even sure if Cryoport is actually being used for this treatment, but I do recall some slides of the Northstar 2 trial from BLUE that showed cryopreservation was part of the manufacturing process for Lentiglobin.
From Motley Fool:
Zynteglo: Positive opinion
Until recently, this experimental therapy has been known as LentiGlobin because it uses a lentivirus to insert functional hemoglobin genes into stem cells that produce new blood cells. This treatment could be used for patients with transfusion-dependent thalassemia (TDT) and sickle cell disease (SCD). Both of these conditions are caused by dysfunctional genes for hemoglobin, the protein in red blood cells that carries oxygen to tissues that need it.
Recently, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency recommended conditional approval of Zynteglo for TDT patients who can't find a matched stem cell donor. If the European Commission follows CHMP's opinion, as it usually does, this will be the first available treatment for TDT besides frequent blood transfusions, which are painful, inconvenient, and expensive.
If approved in the EU in the first half of 2019, and the U.S. in 2021, annual Zynteglo sales could reach $1.12 billion in 2023. Partly because it looked extremely effective in the Northstar-2 study, where 10 out of 11 treated patients had stopped receiving blood transfusions and had hemoglobin levels up near the normal range after three months.
Around 60,000 people inherit some form of beta-thalassemia, and a large portion of this population could be eligible for treatment with Zynteglo. That's probably enough to drive blockbuster sales on its own, and approval for SCD down the line could push this gene therapy even further. In the U.S. alone, there are about 100,000 people living with SCD, and perhaps a million worldwide that could use a treatment option. Misformed hemoglobin causes red blood cells to flatten out in a way that isn't helpful. Sickle-shaped blood cells get stuck in blood vessels, effectively strangling the organs they service and causing a great deal of pain along the way.