I've been on this MB board for a long time. I didn't freak out on the first, second or third Iluvien CRL's. I invested in pSivida for one reason; the Bio silicon platform. This is what "pSi" means; it means nano structured silicon. Many investors in this company are rattled by the 25% drop in SP post Iluvien " approval". I'm not happy either. I wish we were trading much higher. Investors have also been anticipating pre-clinical data that defines, kind of, sort of where we are with this pipeline that's been touted as so promising. Tblow has spouted that the in vivo data is somehow bad and that Ashton is scrambling to find something that works. Not so. Ashton came from his former company (CDS) acquired by pSivida for his technical prowess. He is pSivida. His former company was acquired for roughly the MC of pSivida "right now"; 105 Mil. He brings to the table immense skill and is developing this nano structured bio silicon with the same development team they've had for years. pSivida is working with huge companies, showing how their technology works. It's long been understood in the science community that nano structured pure silicon that is electro chemically etched can be used as a drug delivery vehicle. In vivo studies have been done extensively in rabbit eyes and found to be " VERY WELL TOLERATED''. Please, Google "nano structured silicon" and do some DD through the many abstracts available . These were not done by pSivida....they just "OWN ALL THE PATENTS" to the technology. I promise you when pre-clinical data is out for this platform, it will make huge waves in the science community. For the whiners on this MB, go buy some P&G, you deserve each other.
Did you take chemistry in college? Tethadur is very simple chemistry. It's electrochemically etched pure silicon to form hollow tubes that can be charged to receive a biologic of an opposite charge; on the micron level (solar panels-get it?) Oh, the pure silicon is inert. It won't react to anything. It can be heated, chemically or heat treated and yet it still won't react. Pure silicon has a melting point of 3400 degrees F. Now, wrap your little brain around the fact that it's Bio Erodible in this form, creates silicic acid and is excreted through your kidneys naturally and with great ease by your body. You still don't get it do you? Stop thinking so short here. Expand your time horizon to include 15'. I'm going to rip you a new one with every single Tethadur accomplishment. Now, you just *&^ me off.
Alimera might be getting some legs with Summer Street Buy rating and PT. Finally, analysts are picking up on Iluvien as a real competitor to the Ozurdex - Dexamethasone 4 month treatment. Anything good with Alimera might drag us up with them, while we wait for pipeline data. So, though we all hoped we'd be in a better SP place at years end, other investors have an opportunity to jump in on the cheap with both companies. Let's hope that continues.
Agreed. I'm not that kind of investor. I use different vehicles for solidifying my financial future; like good real estate. I'm good for the long haul in PSDV. But yes, I wish Data were out. I invested in this company for their Biosilicon platform, now it's backed up with Iluvien. Good data and the resulting clinical advancement will make pSivida a worthwhile investment. I'm sticking around and continuing to pick up shares on the cheap. It is a fair question as to how low it will go. Either way, when the management comes out with it, it will be very good. I guarantee it.
Flex, It might be world peace that comes first. Data is pushed back to most likely 15', more than 6 months late. What would be the reason for that.......? Don't know, so yeah, world peace is looking more likely to happen first.
Let's just hope that something of interest happens with ALIM, regarding M&A speculation. Having big pharma jump in for Iluvien would be a shot in the eye for everyone. We'll see.
For all the good stuff that happened this year with Iluvien we're still a micro cap with low institutional ownership. We now have low volume trading days and what seems to be little interest with investors while the SP is close to a 52 week low. After all, we're a company who's revenue is dependent on another company getting it's act together, to put its product in the hands of retina specialists. This might take us into mid 15', with little revenue coming in until maybe next year from Iluvien sales, right? So, WTH. I still believe the real future of the company is in delivering the biologic drugs that are so prevalent in big pharma's margins. So, we've waited and waited for data and it hasn't come yet regarding Tethadur; the promising pipeline. I believe that with the cash lined pockets that pSivida has now, management is filing more patent apps and preparing the data for potential publishing. This would be the professional way to deliver the data to the scientific community wouldn't it? I've always been impressed with managements focus regarding the science. The last Avastin data was investigator sponsored and delivered at the ARVA conference. We'll soon see and I'm hopeful that when data does come, it will be very good indeed. Wouldn't this spur institutional investors in a big way and change the trading paradigm going forward? The last Patent application was about Durasert coatings used in concert with Tethadur.....this potentially gives us the long term sustained release( 6 months-1yr) Big Pharma needs, in a big way. This might be what Ashton was talking about in the last CC regarding competition. Data like this hits it out of the park and is worth the wait. But until then or ALIM M&A, this might be our range.
PR, You may be right here. I just like to see a licensee take biosilicon into the clinic for any reason. Time will tell, as will the market as to whether there is
beef in the sandwich or hot air. You're points are good.
Gee. Would this be just one reason for delaying data? I say yes. Patent applications are enough to explain this. Keep it up bud.
Terry, This more appropriately describes some of the coatings that were shown in the pSivida pre-clinical release graphs. That was presented by Hong Guo in March of 13' in San Fran as I recall. Great find again. So, with a polymer coating what kind of time horizon is pSivida focused on regarding biologic release? Either way, this is why I'm holding stock in pSivida.
For those who are not impressed with Oncosil and the pending pancreatic PIII trial they have planned, take a breather. This is as much about Biosilicon in a late stage trial and another licensee that sees rather obvious value. Additionally, pSIvida has rights to all the data....now what's that worth? Isn't it about getting technology out to licensees and having them pay fees and development costs, while pSIvida has rights to data? What do you think?
JD, I find the Roche connection just as interesting with Mr. Kenny. Now, this is not Tethadur, though it is biosilcon and has nothing to do with Durasert. I think the profit split is 8% to pSivida. I'm just happy to see another licensee taking the biosilicon platform to PIII, pSivida has rights to all the data, just as with ALIM....that's the news.
Disagree completely. pSivida initially started the PI-II trials and it was the first to demonstrate the use of the bio silicon platform. The early stage portion of the trial showed that the drug was very well tolerated and that the average life expectancy was extended to 18 months. Granted the PIII will have more patients. All of them have a death sentence. So, ask them if they'd like to live a bit longer and better. Oncosil has a market cap of 40Million.
Oncosil- pSivida licensee to take the pancreatic PIII forward, has a new CEO. Typical no news deal for pSivida though:
SYDNEY, Tuesday 11th November 2014: OncoSil Medical Limited (ASX: OSL) (OncoSil, the Company) is pleased to announce that Mr Daniel Kenny has been appointed to the position of Chief Executive Officer, effective 5th January 2015.
Mr Kenny is a highly experienced and successful biopharmaceutical sector professional, with almost 30 years' experience in the global pharmaceutical industry, including senior roles with Roche, Allergan and Baxter. He also has more than 10 years experience in clinical research in the fields of ophthalmology and HIV/AIDS prior to join the pharmaceutical industry.
As OncoSil’s new CEO, he will be responsible for executing the Company’s growth plans as it drives towards registration of its lead product candidate, the OncoSilTM localised radiation therapy treatment for pancreatic cancer.
Prior to joining OncoSil, Mr Kenny was Chief Commercial Officer and Vice President Business Development at major French biopharmaceutical company, ABIVAX, where he was responsible for the development and implementation of the commercial and business development strategy.
He was also previously Global Franchise Head at Baxter Vaccines, where he successfully reinvigorated the base commercial business and significantly exceeded the business’s financial plan in each of the three years of his tenure. Mr Kenny was also Vice President Baxter BioScience, EMEA where he was responsible for the marketing and key business programmes in support of regional sales exceeding $1.9 billion.
Amongst other roles, Mr Kenny has also been Global LifeCycle Leader for Roaccutane with Roche. He was responsible for global strategic marketing and business development activities for Roaccutane, an acne treatment product, which generated sales in excess of CHF1.1 billion in 2002.
Mr Kenny is a graduate in Physics from the University of New South Wales.
That's been my thesis here with PSDV. Could I be wrong...oh yeah. But the company keeps doing what they do best, finding technologies to deliver drugs. Look at Allergan, they get Dexamethasone to go 4-5 months, with the same side effect profile as Iluvien but only lasts one seventh the time, I say retina docs will choose Iluvien. Even the statement from Paul Ashton last CC went as far as to say Iluvien is a better therapy.....then what else would he say. Anyway the pipeline is worth holding for clarity on.
JD, They would have two weeks to report their form 13, as they have a beneficial interest over 5%. You never know how someone under 5% is moving the stock, just to keep it out of the news and keep the price low. Then again, with retail owners they just may be buying and selling with penny moves.
I guess I don't have to state the obvious. For longs waiting for the pop....it's going to take real news to move us. MM's sell us off as soon as we move up at all. It's been that way for a very long time. We'll go over $5 when something big happens and we may not look back, but for now........this might be our range.
Igon, I, like other longs are anticipating a couple of catalysts. I believe as the Iluvien market is better defined by the Big's, that one of them will snap ALIM up. Assuming that is true, the ramp to market for Iluvien could be accelerated exponentially, due to the Big's capital and expanse in the market already. This could only help pSivida as market penetration would be more rapid. pSivida's 20% is not diminished by who acquires ALIM. Secondly, with the cash lined pockets that pSivida now has, wouldn't it make it more probable to dot the i's and cross the t's with everything Tethadur. Would it also be possible to publish this data in the medical journals applicable to ophthalmology. I say yes and believe when Tethadur data comes out, it will make a big statement to the world for sustained release biologics. MM's have kept the stock price under $5 for a long time. With Tethadur data out and positive, that will no longer be possible.
Billy, Thanks for bringing some sanity to the MB. It got a little crazy for awhile. Longs were *&^@ , but they were ignoring the fundamentals, that you so clearly illuminated. Thanks.