This is Paul Hopper's description via PSDV website:
Mr. Hopper is Managing Director at the Los Angeles merchant bank, Cappello Group. Mr. Hopper has over 20 years experience in the management and funding of biotechnology and healthcare public companies, and has served on the Boards of more than a dozen publicly traded companies in the US, Asia and Australia. Mr. Hopper is the Chairman of Viralytics Limited (ASX:VLA).
You may have read Mr. Smith's recent article in SA stating Tethadur data by mid year. This was backed up a bit by my inquiry to Beverly at PSDV investor relations. From what I'm gathering, is that this data includes that from animals. Could it also be data that would include drugs out of the ocular space? If so, this data might potentially show the myriad of drugs that has often been shown by Dr. Ashton in his powerpoint presentations(PSDV's own work). Drugs such as Herceptin, would have the potential for oncological applications, i.e. breast cancer. Mr. Smith obviously picked up on Dr. Ashton's enthusiasm for the platform. The good doctor is very careful about everything he says. In this case he might be letting the world in on the multiple years of work; he's been honing his fine craft of nano silica structuring. I think the data is going to rock. Knowing the data will be released will generate a buzz for sure, especially if it's good. I don't believe for a second it's anything but stellar. Dr. Aston holds over 1.05M shares of the company. I wrote this earlier in January:
mickmack50 • Dec 13, 2013 3:06 PM 3users liked this postsusers disliked this posts0Reply
OK, This Is What We Do Know
There is no question that PSDV wins the 2013 "can you keep as secret" award. Investors like myself are just chomping at the bit for data that may give me/ us some idea as to how the company is progressing with its Tethadur platform, along with the billion dollar drugs. Good data would most likely mean Big Pharma will be getting in line to license and/or move their drug product into the clinical setting, or both. What we do know is Paul Ashton isn't saying much yet. BUT!...in the last 10Q report, the company description clearly states that they can deliver biologics. over "weeks, months or years". This is the first time I've ever read this statement under "company description". I invite all to read the last 10Q. The company description is very close to the beginning. Paul Ashton wouldn't allow that to be stated, if it were not true.,he is so careful and matter of fact (to a fault). So, I can only imagine what he and Lori Freedman are doing behind the scenes to build shareholder value, 2014 will be "showtime". Big Pharma wants and needs it badly, and PSDV's going to be there to deliver it. Less
Wrong. The Tethadur platform is a Biosilcon platform. The Biosilicon platform has been through a PII Pancreatic trial. Oncosil has purchased the rights from Enigma and will take this through PIII trials for pancreatic cancer. This generates a mere 100K /yr. for PSDV, with a percentage of the gross. Ashton is being careful here. He's got the big boys on board and they are dealing with serious delivery implications; like billion dollar drugs with 200 billion dollar companies.
Now, why in the hell would Oncosil jump on board if biosilcon had any issues with toxicity? This platform, will by the end of this year, will prove to be PSDV's mainstream "HOLY GRAIL" platform. I guarantee it; from a licensure standpoint. I hope Hernando is reading this.
Take a deep breath now, PSDV never for sure committed themselves to a date, though one may have been implied in various statements that got twisted in third
person. The stock of PSDV isn't over volatility. I would say however that the worst is most likely behind us. For all the reasons I've mentioned, on any given day a license deal or better could "miraculously" materialize out of thin air. I've been in the green for a long time.
For all of the reasons that I've ever mentioned, I believe a firm new floor is underneath our little company, with Iluvien in light favor of the FDA and labeling details underway. Perhaps we look to the next level. Not to say we won't see four bucks again. It wouldn't matter, longs are in this company cheap and over time. "If"" preclinical data is strong, we'll just see the licensing deal, data perhaps later. There are a couple of big Pharma's in and nobody is saying a word. The next level is; the good doctor (as Eyeknow would put it) announces a license deal with Big Pharma and we go up $10 on the gap move. In the meantime, from an investment standpoint, entry here is pretty safe.
First, I don't bash this company. Did you mean pumper? The answer to that question would be no. I have however, been a long time investor that sees this year as pivotal in pSivida's process. I'm a big fan of the Biosilcon platform as I think it will be huge. The applications are beyond anyone's imagination, including my own. Look at REGN and RHHBY, count the biologics in their arsenal and pipeline, then ask if sustained release of those drugs would make them better. I accumulated the majority of my position in this company in the $1.75 range, nobody saw this company as having any potential then....obviously....That's my honest answer.
Mo, Sorry Man. For all the investors that were in earlier, and there are quite a few, it's been hard to believe in a company like PSDV. Much of the rocky road is behind us now, as you know. It will be much easier to hold our shares with a greater upside than ever. This company is so very well managed, and they don't say a word about anything until the check clears the bank. Dr. Ashton is solid.
Sentiment: Strong Buy
Elizabeth, Thanks for your support. I'm glad you held through the rough years, I know it wasn't easy. There aren't many biotech's that haven't been discovered. I do like the thinly traded LPTN and NVAX. LPTN is at nice valuation and NVAX has made a big move this year. It hovered in the low 1's for a long time, you might watch those. As always watch em' awhile and do your DD to see if you like them. You'll see your $6 in PSDV this year I'm sure. I'll continue to hold mine as I believe the upside will start to reveal itself with a Tethadur license deal with big pharma taking it to a clinical trial, and paying the bill.
Elizabeth, ACAD was a stock that I just never pulled the trigger on. Shows you what I know huh? What a huge move it made from it's lows too. Good for you. It would be hard not to hit the sell button at $15 with your basis as it was. You just never know. Thanks for checking in to the MB, and the support.
Terry, Thanks. Heat resistance and the ability to sterilize biosilicon is a tremendous advantage here. I'm a bit surprised that pSivida made very little mention of Oncocil buying Enigma Therapeutics (who has rights to the Brachysil Pancreatic process) . Imagine that, pSivida all hush, hush about a Licensee. Anyway, You're aware of it though, and it was mentioned in one of the last filings. Oncosil is going to continue with that pancreatic trial through PIII. That trial showed clearly that the biosilcon was very well tolerated. I'm going to do a search on Oncosil to see if there is any more news.
Terry, Here's what I just dug up on Oncosil:
OncoSil Medical (ASX:OSL) is a targeted brachytherapy treatment developed under an exclusive worldwide license from pSiMedica Limited (a subsidiary of pSivida Corp (ASX: PVA)) for its proprietary BrachySil™ product that deploys defined radioactive isotopes.
OncoSil™ is an active implantable medical device that contains the radioactive isotope of phosphorus known as phosphorus – 32, which is closely bonded within an internal microcrystalline structure. The device is a beta emitter that is highly cytotoxic (toxic to cells) that are within a short target range of around 1 cm, and has poor penetration beyond that distance. The device is well suited for local administration to tumours, while minimising systematic toxicity.
In February of 2013 NeuroDiscovery Limited announced acquisition terms for a 100% interest in U.K. based cancer treatment company Enigma Therapeutics Limited and ownership of OncoSil™. The purchase was completed in April of 2013, and included payment of 75 million shares, and name change from NeuroDiscovery Limited to OncoSil Medical Limited.
Enigma had already completed two successful Phase II studies of OncoSil™ in pancreatic cancer that included a total of over 10 years of investment and research in patents, pre-clinical, clinical, and manufacturing trials. OncoSil™ is classified as a class III medical device that is implanted in the body, and does not release any drugs or chemicals, or interact in any other way with body tissues.
Hey All, Like I was telling Terry, PSDV doesn't say boo about it. They do mention Enigma in their SEC filings. But this is more on PSDV's Licensee for the Brachysil biosilicon trial. Oncosil is carrying forward now to PIII:
OncoSil has completed four clinical studies, two of which were for the treatment of pancreatic cancer.
These have demonstrated that treatment with OncoSil™ was:
- Well tolerated;
- Easy to administer;
- Stabilised the patient’s disease in most cases; and
- Provided good pain relief.
The results have prompted the company to move forward with a clinical study with 150 patients, to be conducted globally in 20 centres in Australasia, Europe, United States and Singapore.
This study, scheduled to commence first quarter this year, will compare patients getting standard-of-care with patients getting standard-of-care and OncoSil™ treatment. The key study measures will be:
- Patient survival;
- Time before the cancer starts to progress;
- Quality of life; and
- Pain relief.
OncoSil Medical is consulting with key experts in the area, as well as regulatory authorities in Europe, Australia and the US, to ensure that the study will meet the needs of the Company plus the needs of patients.
It is anticipated that the majority of patients for the key study will be enrolled within 12 months after first patient enrolment and it is expected to take around a further twelve to eighteen months to evaluate patients and to determine their progress.
$1.2 billion market by 2015
There is a major unmet clinical need for pancreatic cancer treatments, with 280,000+ pancreatic cancer incidence yearly world wide, with around 45,000 new patients diagnosed with pancreatic cancer in the U.S. each year.
The world market for pancreatic drugs is projected to exceed $1.2 billion by 2015.
OncoSil believes that new implantable radiotherapies such as OncoSil™ may have the opportunity to treat the disease and the debilitating pain associated with it - and fill a major unmet medical need in pancreatic cancer treatment.
The completion of the gap analysis paves the way for OncoSil to submit an Investigational Device Exemption for its pancreatic cancer treatment medical device and represents a firm step towards commercialisation.
There is major unmet clinical need for OncoSil's localised radiation therapy potential solution for pancreatic cancer.
In addition, medical devices require significantly less funding and the time required to undertake a registration study with faster approval compared to drugs. This is likely to result in better gross margins.
On our preliminary analysis, Proactive Investors estimates that OncoSil has an intrinsic worth of between $0.20-$0.30 within six to nine months.
As I understand, the terms are a 20% profit share, like Iluvien. There is a 100K year license fee to PSDV. More specifics available from Beverly at PSDV IR. The market is expected to be 1.6B by 2015.
The shorts were licking they're chops when it hit $8, looks like they're is still some meat on the bone for them. You only have a couple of options; sell and make them happy or buy some more.....that's what they'll have to do at some point.
Terry, I haven't read this abstract.Good Stuff. But I'm familiar with some of it's disclosure regarding biosilicon. So, is PSDV waiting until they work out a license deal with all their patents comfortably locked up, or finding a suitor that will take it to the next level? I'm getting from Beverly, that mid year( July 1st?) there will be data release of the Tethadur pre-clinical.
PSDV's pretty good at this stuff, I just know Paul Ashton has positioned himself and the company for big things following the release of this data. We are ultimately looking for 6 month release profile of the biologics like Lucentis, Avastin and/or Elyea. Must also mention the systemic drugs that may be very interesting. Pre-clinical data should be a sign of things to come. Patience is the key here, PSDV is dealing with Big Pharma and very important drugs.
I thought they'd make it to March 1st. I believe I'm right. What a bunch of Doosh Bags. This is from their 10Q.....:
The Company expects its current resources to be sufficient for a period of approximately 1 month unless additional financing is received. Management has determined that additional capital will be required in the form of equity or debt securities. In addition, if we cannot raise additional short-term capital we will be forced to continue to further accrue liabilities due to our limited cash reserves. There are no assurances that management will be able to raise capital on terms acceptable to the Company. If we are unable to obtain sufficient amounts of additional capital, we may be required to reduce the scope of our planned development, which could harm our business, financial condition and operating results. If we obtain additional funds by selling any of our equity securities or by issuing common stock to pay current or future obligations, the percentage ownership of our stockholders will be reduced, stockholders may experience additional dilution, or the equity securities may have rights preferences or privileges senior to the common stock. If adequate funds are not available to us when needed on satisfactory terms, we may be required to cease operating or otherwise modify our business strategy.
spre, You're smoking crack again? Alimera will have to re-flile the NDA with the FDA. Most likely, another PDUFA date will be issued. So, let's say ALIM refiles by March 31st, then another PDUFA date of 6 months. Could be fall cowboy before the Fed's respond. My guess is that they won't take the 6 months, but it's just a guess.
Big difference JD, the 25Mil is due 30days after FDA approval. It looks like it will get paid now, with ALIM raising capital today. It's all good news. Still, no
value given to PSDV pipeline. Great entry point for new investors.