At some point in a card game you just lay your cards down, you have what you have. That's true in whatever business you're in as well. If you've got a way to get 50 miles per/gallon on a 6500# truck, you're going to get some customers. It's just the way a market economy and a society like ours works. Soon, alternatives are going to make a move.....it was not today however, but soon. With drugs, it's a delivery system that will increase our MPG. If you get 6 months out of a drug/delivery platform that increases the efficiency 600% with the same efficacy, you're going to get some customers. It's very simple. The beauty of Tethadur is that it is pure bio-erodible Silicon that you can electro-magnetically shape and charge, to fit some of the most sensitive and fragile proteins in the drug industry. I'm familiar with the properties of silicon through my high temp ceramic background. The fact that pSivida found a way to manipulate an inorganic, completely stable, refractory compound is mind boggling. Oh, and to fit within a 10 micron matrix? Yeah, I'm sayin' it's worth more than four bucks. Don't worry longs, the time to short this company is running out very soon. I'm betting the house. If I'm wrong, we still have Medidur and Iluvien, that's worth more than 4 bucks too.
Joel, I know. This isn't a company. It's a post office box somewhere in Nevada. Call the city that this company calls home, no one has ever heard of it. It's a shell game and investors lost, PERIOD! I've got some land to sell you after you buy a bunch of this #$%$.
JD, Thanks for your input here. If you've noticed, I've been posting material and articles about the next big issue for ophthalmic biologics; PRICE. Iluvien will start looking real good with price starting to become an issue. Chronic patients are going to thrive on the benefits of Iluvien on two levels- price and efficacy.
Now that countries are screaming for Avastin use in Ophthalmology (not even fricken' approved for such use) all because of costs. It gives everyone a heads up on where the payers will drive the market. pSivida is as well positioned for this transition as any company in the world. Yes, it does mean big pharma may be getting less for the drugs that are not administered monthly or 8 times yearly. It's going to change fast because there are new drugs coming to the market in ophthalmology; and very quickly. It's very fluid and I can guarantee that price forces will dictate what drugs and for how much. Successful sustained release will further enhance these market considerations. Companies that are not factoring these nuances lose.....a company like pSivida is very well positioned for the pending dynamics. When and if Roche jumps on a license deal, or a bid for acquisition, it will bring huge validity to all these topics we've discussed for a long, long time. Either way, we've rolled the dice and have taken our chances. I still like our chances.
Frank, It's nice to have you back posting on the MB. It's a bit funny to project prices for this company. Many on the MB who are longs have had a historic feeling that we've been way undervalued for years. I mean, if we can successfully delivery biologics, how on earth is the stock price in the single digits. I know that we are a company with a platform technology that has yet to be proven. This said, data may materialize where we finally state the probability that we can deliver the biologics to any part of the body and up to a year in sustained release. Now, that should garner some interest by the investment community. Iluvien, like Medidur is a completed product for pSivida working their way to approval. So what the heck has pSivida been working on in the last three years? We know for two they've had evaluation agreements with "global pharma's in Ophthalmology". Now we await the results. It has profound implications for investors and medicine.
Kool. This is important news . It shows how increased efficacy has tremendous potential to
stimulate growth. Here's a pasted piece that explains how Fovista sparked Novartis' interest, In my opinion, Tethadur will also be a game changer in the efficacy game. After all ,better is better:
Rather than displacing those blockbusters, Opthotech's Fovista hopes to make them work better. In phase 2 trials, patients taking Opthotech's Fovista alongside Lucentis' saw their vision improve by 10.6 letters on a standard eye chart, versus 6.5 letters when taking Lucentis alone.
That efficacy suggests that Fovista alone could have blockbuster potential that justifies its current $1 billion market cap, but Opthotech is even more intriguing now that Novartis' has paid Opthotech $200 million up front and agreed to $1 billion in milestones just Fovista's non-U.S. rights.
Very good points Tom. I wouldn't have believed it several years ago. It does however seem that regulatory BS exists in the US and is the fault of the fricken' FDA. If one just looks at Iluvien as an example , it's not hard to figure the #$%$ that goes with it, three CRL's then labeling?. I feel bad for biotech's having to work in the system. I believe it's totally corrupt. Cannabis is a schedule 1 drug? Yet, the US government owns all the patents on it medicinally? Right.......The EU is much more progressive and for companies like pSivida , their technologies are going to be very well received by the regulatory powers that be. Roche should be jumping all over it soon enough.
I am sick of watching how the US regulatory systems operate and am somewhat ashamed of how the congress used to be able to trade on the information that the FDA had yet to put forth to the public; probably still do. Is that a level playing field? As I believe Roche is a real potential suitor, getting pSivida technology into the EU regulatory body can't happen soon enough for global medicine. I'm not sure we'll ever have a level playing field in this country.
Tom, the interview with CEO really spells out the path for big pharma, in my opinion. He states rather clearly that those (big pharma co's) that can be innovative or make drugs less expensive (cheaper) will be successful in the coming years. What other way would a company do that? It's not easy for companies to make "cheaper"drugs.
Unless you find a platform that can sustain release those drugs over time, with similar efficacy........For those who have held pSIvida's stock over the years for it's Biosilicon platform, it's going to be a very telling year; irrespective of Iluvien. This is where the great management of pSivida has teeth. No BS, just good technology. Working with "global pharmaceutical's" has a way of tempering your BS factor.
Terry, Roche is so much the suitor for pSivida. Avastin will be the poster child for sustained release throughout the body. There will be mounting pressure for big pharma to jump on license deals in sustained release biologics. Price pressures have been well documented on this MB, there can be no dispute as to the issue. Countries are tired of paying the big bills in ophthalmology alone. So, will pSivida give way to a suitor or will they milk the potential in license deals? It's going to be an interesting 6 months, don't you think?
Roche will either bite on the Tethadur license deal or buy the company. I've waiver'd over the years, but I still think Tethadur data out soon will initiate the catalyst. The EU is going to be so much more regulatory friendly to Tethadur. The FDA will approve it only when it's showing real promise in the EU. So, where is the pSivida Tethadur work done you ask?........the UK.
ZURICH--Swiss drugs maker Roche AG (ROG.VX) isn't interested in making large acquisitions and will continue to focus on buying smaller companies and entering into partnerships to boost its pharmaceutical and diagnostics businesses, Chief Executive Severin Schwan told Finanz und Wirtschaft in an interview released Saturday.
The company, based in Basel, Switzerland, has restricted itself to making only small deals since it bought the share of Genentech which it didn't own, in March 2009.
"We are certainly seeing a consolidation in the pharmaceutical industry, and my theory is that in a couple of years it will be mostly drug makers who are either innovative or successful in making cheaper drugs who will be successful," Mr. Schwan told the newspaper.
Roche isn't interested in the potential tax advantages from large takeovers, "and we examine primarily whether a product or a technology has the potential to improve our therapy standards and whether it fits into our pharma and diagnostics businesses," Mr. Severin said.
The Roche CEO's remarks come after the deal announced Friday, in which Chicago-based pharmaceutical giant AbbVie Inc. ( AbbVie Inc) swallowed the U.K. drug maker Shire PLC ( Shire PLC) for around $54 billion, in a transaction aimed at lowering the U.S. company's tax burden. Earlier this week, Mylan Inc. ( Mylan Inc) said it would buy Abbott Laboratories' ( Abbott Laboratories) international generic-drug business in a $5.3 billion deal.
Mr. Severin also noted that the valuations in recent industry transactions were high "and this is another reason why we have been less acti
We all knew data was due out. Now, it seems that Eylea will be another drug that the FDA approves ahead of Iluvien for DME; the same indication that Iluvien is pursuing. Big difference however is that a series of monthly shots are still required initially, I believe 5... to start. Iluvien will still have a place in the market with its very attractive one every three years. Also, there will be the subset of patients that will cease to respond to the VEG-F's... That has been and will continue to be the market for Iluvien. It will take a bit of time to find its way through as an option for the retina specialists, but it should be an attractive alternative in patient interest and cost. The VEG-F's will still be under pressure with the payers. Ophthalmology is a huge part of seeing "RED" for countries paying the bill.
Root. Thought you were just a shorty. Yeah, the trend is down but the volume is light, so no concern with me. I trade the moves a bit, but ultimately hold comfortably long. Biologic delivery has moved into the light for big pharma, something has got to give where less injections saves money and maintains efficacy. Payers are getting a little tweaked over the big bills in Ophthalmology.
Tide, Let's face it, the FDA is full of &^*%. They've been screwing around with Iluvien for more than 3 years, and then they go into labeling discussions in November, following the 3rd CRL. C'mon give me a break, that's criminal because it was so manipulative. They've approved Ozurdex by Allergan now for DME (a steroid) that has a four month release rate and the same issues with elevated IOP that Iluvien has. Now, the Biologics (Eylea) are poised for approval for the same indication in August. Iluvien will be the last one approved, but the first one ready to be approved, more than 3 years ago. That's fricken' BS. pSivida's strength is still it's pipeline. I know the market doesn't see the value of Tethadur yet, but the analysts are starting to see it. Like many on this MB, we've all waited for years for this next 6 months worth of data. If Paul Ashton says we're going to have some catalysts......I dang sure believe him. Absolutely no reason not too. Good luck with Biodelivery too. The recent downturn is just a buying opportunity as the volume was very light.
This increases PFE's exposure to more ophthalmic pipeline of drugs.
InnoPharma’s current portfolio includes 10 generic products approved by the United States (U.S.) Food and Drug Administration (FDA). The company also has a pipeline of 19 products filed with FDA and more than 30 injectable and ophthalmic products under development. The company seeks to develop novel formulations of existing drugs, including hard-to-make products, such as those that require complex manufacturing capabilities or have bio-equivalency challenges, in areas such as cancer and central nervous disorders.
“Today’s announcement is an important milestone as we continue to look for innovative growth opportunities for our sterile injectables portfolio, which will increase to seventy three products with this acquisition,” said John Young, group president, Pfizer Global Established Pharma (GEP). “InnoPharma’s technical capabilities in bringing complex generics to market, coupled with its strong talent and product pipeline, build on our efforts to develop and commercialize critically important medicines for the patients who need them.”
Pfizer Injectables is part of the Global Established Pharma business and includes the manufacturing, production and sale of human pharmaceutical and surgiceutical products. The current active sterile injectable portfolio consists of 44 products with over 190 presentations in the U.S. The new Pfizer portfolio of seventy three products will include currently marketed, as well as products filed with the FDA.
Kool. The cash from the Iluvien would be a drop in the bucket towards the cash needed to fully develop Tethadur. Yeah, if PSDV holds it's own and does not find a suitor, we still build momentum with Tethadur development. Yet, time is a compelling variable that big pharma understands more than ever with patent cliffs and cost pressures (i.e. Avastin/ Ophthalmology) . pSivida should be properly valued. The pps should be 300% of today's trade IMHO. We won't be able to stop the train.
I've been watching this #$%$ed company for years. I must admit their initial propaganda machine worked several years ago. I dipped my toe in for a couple of shares. Then, as typical with the #$%$ed company, it sold off immediately to the point where it is today. They were #$%$s when they were Kodiak Mining......I just can't wait to see them take their last collective breath. Sorry bag holders. Matthew Worrell, now there's a #$%$.
I'll admit that I've gone back and forth as to which big pharma is going to bite on a pSIvida acquisition. We all know about PFE and the long standing position they have in the company and the latanoprost PI,PII trial underway. Is no news good news? Maybe. However, I keep coming back to Roche. One of the huge reasons in coming back to Roche is not only their biologic position with Lucentis and Avastin but for the potential that the EU will be much more friendly towards the Tethadur technology. Let's face it, the FDA still sees cannabis as a schedule 1 drug; the most lethal (Fricken #$%$). The regulatory path for something as progressive as Tethadur just may need the EU to push it through faster. The FDA will pull it's collective head out one day, but not in time to be truly progressive. To say that the agency is archaic is an understatement. They should be ashamed of themselves on the Iluvien gig alone, especially when you consider that Ozurdex got approved first for DME (the Dex steroid). Have I been wrong before? But, I think this one is close to a no brainer.
Terry and JD. Together you've both brought a keen sense of the nano-silicon technology for everyone to read and grasp technically on the MB. Nano structured silicon is actually fairly simple chemistry. It's simplicity is a huge benefit . The complexities in the science come when companies like pSivida learn to give it opposing charges, relative to the drugs it is meant to carry. Then, vary the pore sizes to further enhance the loading and release rates of specific biologic sizes. This is the huge area that pSivida will someday soon show their expertise in. The knowledge of nano-psi is only getting a foothold from the public point of view; long known in the science community. Soon, with license agreements, big pharma will be motivated by the need for greater drug release efficiency and increased patient interest through sustained release. It's going to be a whole new ball game for pSivida and the companies they work with. It's been a long time coming as we've all been very patient with our investment positions. It also has enabled those who read this MB to gain an understanding of what nano-pSi is all about, and it's huge potential for medicine. It's going to get very interesting very soon. Good posts as always.
JD, Our timeline is getting real close now. Perhaps it is a matter of getting Iluvien - US approved to more easily value pSivida. But, either way those who always thought about the M&A potential of this company is right on. Like Terry said, the two year anniversary of the evaluation agreement comes at the end of July. Can you imagine how difficult it is to keep data under wraps.....we're due. Lot's of upside from here bud!