Few would deny that this year in Alimera's short US marketing history that the lack of "J" code has hurt the numbers in a big way. So, with the idea that it becomes available January of 2016, we should start to see solid sales going forward. No doubt the $8.5K per insert is a problem for doc's to eat , knowing there is a fairly significant timeline in getting paid back. I see Alimera SP right now very attractive, even though there may be some fundraising going forward, and who knows when. So with all the drama of the FDA and three CRL's due to IOP, things have settled out a bit. The patient population has been further defined to control these IOP issues and 2016 should be robust for the company. Though I hate to agree with Hernando, due to his pompous
vitriolic attitude, he might be spot on about one year from now as it relates to the company prospects.
Lets hope we hear something about HSS soon. It'll be a nice addition to the Medidur news regarding the trial length. In the meantime.....the bio's that don't have anything going are getting hammered. It's about time for valuations on the lofty bio's to get adjusted. I also think ALIM is way oversold. It's going to make some money next year.
Oh Gee....Ozurdex only had one trial for one indication (RVO) then gets FDA approval for DME. Then, the FDA says to pSivida......no, you need a second trial for six months. Then, the FDA comes back and says "only kidding" , two six month trials will work. Not to fricken' mention the saga of Iluvien's "THREE" CRL's, then the follow up ADCOM plan, then canceling that and approving Iluvien with a label restriction. What BS. Yep, Allergan, the multi-billion dollar company gets its way and the real innovation leader micro's get kicked around on a daily basis. Finally, someone at the FDA pulled their collective heads out of you know where.
pSivida's data for posterior Uveitis is going to be rock solid . Someone at the FDA perhaps saw Dr. Jaffe's study from Duke and was perhaps persuaded with the overall stellar results. Data talks and if pSivida had a meeting with the regulatory agency. I'm sure they presented very compelling "data". What a crock and congrats to management at pSivida for being patient and persistent.
Was just sent a shiny new fact sheet from Bev at IR. It lays out specifics about what's going on in the company and the anticipated 12 month events. This includes an IND for biologics and Tethadur, wet and dry AMD pre-clinical data and or course the Medidur PIII trial data. I just bet it finally moves the needle.........contact IR....it's worth the read.
I see the point here. At least pSivida will have the "option" to sell the rights to the drug. It will be " all theirs" should they decide to do so. And yes, watching ALIM struggle to get Iluvien launched defines the arduous
and daunting financial task to launch a drug. At the same time, I'm wondering if ALIM is going to have to raise capital. This might explain the steep drop since their earnings call.
Well, have to disagree here Hernando. Medidur for Uveitis will show great data and you know it. It was always the indication that pSivida made a point to make an exception about in the license deal with ALIM. Both companies will be well served with the insert. Naturally, it's all about data next spring. We do however know that the Duke study shows the complete potential with the range of patients in the 3 year study. pSivida will have a potential of 200K patients......yeah, that's a bunch and it's all theirs.
D, We've all thought about those acquisition possibilities. But the Kool may have hit it on the head. It is a matter of 16' and 17' setting up well with data. It could be coming from various angles too. Medidur for Uveitis for sure. Iluvien sales combined with the potential for an out license on the Durasert platform. Perhaps with the new big pharma having just inked an evaluation agreement. Then, if they "ever" get Tethadur into the clinic...........I personally, am giving more thought and weight on the Humira gig. It's apparent that it's on Paul Ashton's mind, as he reminded us of on the last CC.
Just hurts to watch the current manner in which we get dinged on low volume. GL.
Down 2% on 29K shares.? Is it the bio space in general? Is it this stock in particular? Are investors just wanting out of the market? WTHeck? I don't want to look back on the 25% we've lost this year. pSivida investors thought for sure......the crisis was over with Iluvien. But, I guess not.
Hernando, We've had many disagreements. But, I agree with the Alimera story right now and find the valuation very appealing from an investment standpoint. I also now see the time horizon for the PSDV pipeline to mature. I've come around on the Iluvien story for awhile now. I know it will be player in the space of DME; just a good drug. So,.....why the sell off of ALIM. I own a bit now and am puzzled, not to the point of selling.....just puzzled at the valuation.
Hey guys. Glad the article came out quoting Paul Ashton. It is a matter of cost effective measures being taken to curb the spending. 24 shots of Eylea vs. One of Iluvien. I still don't see why ALIM is getting slammed by the market. Iluvien will prove to be cost effective and the will demonstrate efficacy too for DME. This is where the solid nature of pSivida management has some real value. Lot's of bad bio's out there creating the bubble effect and taking us down with em'; hate that.
Yeah, yeah.....I know. Longs in pSivida have waited two years. Or, it just seems like two years. Paul Ashton did make the statement how he looked forward to sharing pre-clinical info on Tethadur. Well, it didn't happen exactly that way but we were informed as the progress being made along with the complications and the nature of the "sticky" Tethadur , getting the drug loaded biosilicon through a needle. Fair enough. Science aint' easy baby. We longs do however know that "if" drugs like Humira (mentioned by Paul in the last CC) coming off patent very soon, could be used as a bio-better with Tethadur....perhaps pSIvida get's noticed and moves forward. The platform needs a anchor pharma to take it to the clinic. So, with the statement from Paul in the last CC, stating that Tethadur might be going into the clinic in 9 months........maybe something is happening. News on any level would be helpful wouldn't it? I hope Paul gets out and plays a round of golf in Scottsdale this week as he spreads the word about ophthalmic drug biobetters. The ice is thin in Watertown.
Bohn, I guess I don't get what you did or why. I know that ALIM has had a tough year with the EU, but it's the US that's going to move the needle here. Frankly, I'm a bit surprised that it's not over $10, with knowing there will be a market for Iluvien when the cost analysis is done by insurers. This stock is pushed around by the market makers to scare the living be jesus out of you and leave. Glad you're back , I hope you stay.
"Clinicians have been waiting for an IOP-lowering product that targets the diseased tissue,” says Dr. Richard A. Lewis, Aerie's newly appointed chief medical officer who is a glaucoma specialist in Sacramento, California. “None of the treatments currently in the market have this unique function. The Rhopressa efficacy data we see in these Rocket 2 results point to a potential breakthrough for our glaucoma patients."
Kool, Just for the record. pSivida was incorporated in US in 2008; the pSivida public company, which acquired Control Delivery Systems in 2005, was founded in 2000 – and Control Delivery Systems was founded in 1991.
D, We've all given lofty thought to pSivida's potential valuation. It is a matter of holding to find out. If there is another license deal for the Durasert platform , it could go far to bringing attention to the idea of years of therapeutic delivered with the daily micro gram action. That's Paul Ashton's whole thesis for small molecules and many indications could benefit from it. Then, there is the Tethadur platform ......If you listened to the last CC you heard Paul mention the potential to carry Humira, which is coming off patent soon. Could it be that the myriad of things investors have been waxing poetic about regarding the company might actually be on the horizon? It just might be and the overall valuation of the company could change not only quickly but dramatically. GL.
Yep, Rick Perry would have been another great president. I really liked his new glasses that he sported. Must have been a team effort to try to make him "look" smarter than he actually is. He, like the other Texas presidents and candidates that came before , did and could have changed the world...........not. What a
bumbling dooshbag .