For those that forget, don't recall or never heard the results from Dr. Jaffe's Uveitis study.....here's Paul's response to the data. Now, granted the patients in Jaffe's study are not typical of those in the PIII trials. Data from the first is being evaluated as we speak. We are supposed to hear the results by years end. Let's hope for investors that we do. But here's Paul Ashton's response to the Jaffe study at Duke University:
“The results in Dr. Jaffe’s study are very dramatic. The efficacy of Medidur in controlling uveitis and restoring visual acuity was spectacular. At the extreme, in addition to completely arresting any recurrence of uveitis, Medidur restored vision to two eyes that were legally blind at baseline, improving from 20:400 to 20:25 and from 20:500 to 20:40 at the last follow-up visit. We look forward to the unmasking of the data to view the results for the low dose of Medidur we are studying,” said Dr. Paul Ashton, President and Chief Executive Officer of pSivida Corp.
Just had some thoughts last night while I wasn't sleeping. Started thinking about how pSivida has rights to the very same drug as Iluvien with full audit rights going forward, regardless of whether Alimera sells. Should Alimera find an interested suitor, and they will, pSivida will be in the same discussion for partnering Medidur. No big pharma will take on Iluvien without pSivida as a partner. This could mean that a deal is on the threshold. The timing is more than interesting. Big pharma knows Iluvien is showing great efficacy and that the J code is weeks away. They also know that Medidur for Uveitis is or will be doing the same. Both inserts are worth a ton to big pharma. And, by doing a deal now with both companies, pSivida gets some big cash up front, plus milestones going forward (EU and FDA approval) and revenues for Iluvien are accelerated. What Iluvien needs is a deep pocketed big pharma. What pSivida needs is a partner to light the match and provide some cash to set the Durasert pipeline in motion for dry AMD. This could get interesting very quickly. GL all.
Kool, Glad this piece of water is under the bridge. You hit it on the head......HSS and Tethadur. Might be summer for Tethadur, but the HSS gig could garner some attention on the back of the Medidur PIII news. Either way, nice way to begin the new year. GL
Nord, Been watching it. I'm not much of a graph technician......like not at all. There does seem to be something to it; we'll have to see. I think a license deal would get things moving too.
Think of the margins on these inserts when 290 micrograms go into each insert....that's 290 Millionths of a gram.......of a generic drug. pSivida "ONLY USES" drugs that have reached the generic category or off patent. They take on "NO NEW CHEMICAL ENTITY RISK". pSivida has learned that therapeutically, micro gram exposure to certain therapeutics can manage specific indications, especially in the back of the eye space. How huge is that? Do you think it makes IM or Sub Q injections more acceptable with our antiquated regulatory body? I certainly do. Now, we wait for the HSS deal to lay out. We're just getting started as pSivida branches out into other areas of the body. GL
You've got the wrong guy. I'm bullish on pSivida corp. because in 5 more years it will be a multi billion dollar company......and I own a ton of it. It's not going anywhere but up. I only know tro' because he's posted here for many years. He checks in about 4 or 5 times a year and is a gentleman across the board. What is your angle here?
This is huge. There is no approved treatment for posterior Uveitis in the EU. I wonder now if we'll get a partnership for marketing the product. Then, perhaps the FDA will pull it's collective head out of it's &^% and do the same . Hate to say it...........I told you so.
Oh, and one more thing....pSivida has complete audit rights here. Additionally, rights to the very same drug but for a different indication (uveitis). Any value recognition for ALIM would most certainly benefit pSivida as well. To have a big pharma taking out ALIM could greatly accelerate Iluvien sales worldwide thus building value for the Durasert platform. GL.....c'mon Medidur data.
Fair enough blowboy. My point however remains, both inserts are tightly connected at the hip. There will most likely be little interest in Iluvien without Medidur. They're the same drug. And data on Medidur will make this ever more evident that a license deal just might be in the cards. Now, go stick your head back in the sand.
At some point the shorts should start to cover on the pending Medidur data. The same investigator for the Duke study, Dr. Jaffe, is doing the first PIII trial for Uveitis. It should be very good data indeed. The MHRA might just approve Medidur in the EU on the basis of this data. After all, the EU has seen the drug (Iluvien) work for DME and is well tolerated. Good luck guys.
Terry.....5 programs for a buck a piece. But, let's just factor Medidur , it will be the best in class for the treatment of Uveitis. Even the FDA is going to look a bit #$%$ not to approve early, based on the outstanding data from the first PIII trial and Iluvien's risk/benefit profile. The insert is well tolerated and effective for two indications in the difficult area of back of the eye retina disease. It's going to be a great year and nothing is priced in to the stock.
I'm having a cocktail overlooking my half mile of pure wild trout water in Colorado. I'm a long here and you're a dooshbag ..waiting for tomorrows headlines that may not materialize. You'll be long gone by the time I reap my profits from this company. Paul Ashton is building this company and I trust him; you don't. If you can't handle the price movement of small companies in the capital markets, get the **&^ out of it. But, do us all a favor and just go away. I'm in the green because I've owned this company a long time and I do my best at understanding the fundamentals. You will forever be a dooshbag and bit&^%er . I'm going to forever call you out on your BS.
Hey guys. pSivida so really wants to stand as an independent specialty pharma. They are distancing themselves from everyone until there is material news. Paul never even makes reference to Oncosil on his calls, but it's listed as a licensee on his powerpoint's and in the 10Q's. I don't exactly understand either but suffice to say if they get the Durasert Dry AMD gig going strong with a data buzz around it, then move into the clinic with Tethadur and announce a drug, Oncosil will be way in the back seat. This is why we've been here so long, rambling on the MB. To say it could be a good year for the company is an understatement.
Kool. 52 week high and low in 30 trading days. The $4/share capital raise, though helpful to the company coffers, continues to be painful for all shareholders. Mid February will show the form 13's for positions prior to the end of the year, they might be interesting as the volume clearly allowed for movement.
Wow, what an interesting couple of weeks. Didn't see it playing out this way, but that's why I don't run a public biotech company. Do I wish the capital raise were more than $4....oh yeah. Will there be more clarity when the form 13's come out, hope so; lot's of shares got traded. Hopefully, there will be some general company updates we can hang our hat on. It's been a rough ride for me.....though I'm still way long. Just wish it were summer.........for many reasons.
Terry, Couldn't agree more. We have always been news driven. With the potential news that we may hear in the first half of the year, regarding Tethadur IND, Dry AMD, HSS OA gig moving forward, EU approval for Medidur /uveitis and/or any unnamed licensed deals we don't even know about regarding the Durasert platform. Either way, I've been holding for a big pharma license gig for either platform, not holding my breath but watching and waiting. This price target seems light. GL.
The only folks selling the pSivida stock today are shorts, perhaps trying to take out stops. As volume starts to slow.....they move in. One of these days..........they'll get hurt badly. I can only hope.
I'd love to see pSivida's EU partner.....and we don't know who that'll be, step up and take on the Iluvien product. It will have a niche fit in DME but it might take a big pharma name to sell it. With Ozurdex on the market and filling the short term steroid niche, it's only a matter of time before clients want a more long term
option. You can't blame a patient for not wanting to go get a shot in the eye every four months with a 22 gauge needle. One every three years sounds more tolerable.