Terry, I've always thought they would be acquired as well, once they prove the technology. I believe that is why they are taking their sweet time with the evaluation agreements. PSDV is very careful regarding what they say. They are more likely to issue statements on the quarterly filings to educate the investor to what they're up to; rather than blow hot air. I still go back to the last quarterly filing; In it they state that they can deliver the biologics, a first for PSDV to state. They've implied it, but not flat out stated it. That's huge to me, as I've read every one of them for the last three years. The numbers (Iluvien aside) are staggering. So, if Beverly states that she's conservatively following Paul Ashton's lead in stating that the Tethadur data will be presented mid year, you have to be patient and wait. It's really something to look forward to. Investors in PSDV are very comfortable here, it would make traders nuts.
Terry, I'm glad you came to the forefront of the MB. I'm always hoping to get a morsel of info in the upcoming CC next week, regarding Tethadur data release. In my opinion, that should be a catalyst in my opinion. I've never understood the sp movement, especially as to it's trading range. I know we're not generating revenue yet, that's what the street looks for. But wouldn't license deals and milestone payments be considered as revenue? Good post.
Regeneron just announced some revenue data from Eylea for the last quarter. As I do the math it's $6.7 Million/day.....not counting weekends. They're just getting their feet wet here. It's going to grow with additional indication approval...DME next. So, with this being said, does a company like PSDV looks attractive to REGN, as they'll assist in delivering these biologics? Seem's goofy that PSDV's valuation is not factoring this ability in. Nano structure pSi is well documented since 2005 for it's ability as a drug platform. Just Google "nano structured silicon", if you want to blow you're brains out with abstracts. Oh, PSDV has pretty much locked up the patents.
Terry, It's good to have someone else beating the drum for this nano structured platform. It's obvious that it sucks up proteins like a sponge and then holds on to them over long periods of time. So, why on earth is nobody pricing this valuable pipeline of pSivida in? In my opinion this is why; Paul Ashton is working with the largest of the big pharma's on their prized drugs. Even though we know the release characteristics of Tethadur, we also know this is being done in the clean room's of the UK. I've been told that data could be expected by mid year. This gives ample time for big pharma to decide how they'll proceed with the platform. In the meantime
Paul Ashton is very comfortable being his quiet self and waiting as he always has; he knows his day is coming. Plus, by mid year he'll exercise another 130K shares of PSDV stock at $3.51. This is what just might happen
1.) License deal, which would mean nice cash upfront, then tell the world about Tethadur via
the most recent data. That could mean more license deals as big pharma seeks viable
sustained release. Plus, big pharma pays for the clinic work.
2.) Acquisition.The market cap for PSDV is a pathetic 125M. The license deal should be worth
more than that.
3.) This is the year.
Paid Consultant Now?...yeah, right. I'm sure that's worth $8,500/mo. That should finish off the last of the cash and whatever's left of the equity value.
Mo, again you've been an investor in ALIM, not me. What's your gut? I do know that to me, Alimera looks now like a company suited for acquisition. They'll be moving very slow on their own. Perhaps with another company better suited to handle the ramp to the US, someone might be looking at it. That'll push the sp up I'd think. They are poised to generate some revenue now. I'm happy to see Iluvien getting some good mojo going finally.
You could have purchased PSDV for $4.96/share. This was after the first CRL from the FDA of Iluvien. Today you can purchase the same company for .24 cents cheaper, only now we have these few things in our favor:
1. An EU launch of Iluvien with distribution and sales in 2 countries. (400M annual sales projected at peak), France next in line.
2. Pending approval of Iluvien in the US by fall at the latest. (400M annual sales projected)
3. Medidur for Uveitis in PIII underway, with investigator study complete, showing no recurrence of the disease at 12 months and a much better risk benefit profile to Retisert.
4. Tethedur completing pre-clinical trials with several large global pharmas showing stable delivery of biologics; peptides, proteins and anti-bodies. The next Holy Grail of drug delivery platforms, with massive potential.
So, I'm just asking. Is it safe to invest in this company yet?
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.