This excerpt of the transcript was taken from SA. There was misprint of the injection frequency; they showed 82...when in actuality it was 8.
Paul Ashton obviously keeps things close to his chest. As a longtime stockholder, I've been waiting for Tethadur technology to get a foothold into big pharma for years. I now believe Ashton is letting out to the world PSDV's ability to do so. I know there are non-belivers, however I'm not one of them. Biologic drug pipelines will be enhanced through a viable sustained release platform, that is all pSivida's . "ONE" license deal from big pharma will validate the technology's potential. Others will quickly follow: Here's Paul.
Turning back to our product pipeline, we continue to be encouraged by the preclinical testing of potential products using Tethadur. Tethadur is our technology platform that’s designed to deliver peptides, proteins and antibodies on a sustained basis. We believe we can use this platform to deliver drugs, both through a particular location in the body such as the eye, as well as systemically. Sustained delivery of biologics is a very exciting opportunity. Patent for biologic products with annual sales totaling over $50 billion are expiring over the next five to ten years. Sustained delivery could be keys of the BioSimilars and BioBetters for these products.
The biggest drugs in ophthalmology right now are biologics, which while effective require regular injections into the eye, typically 82 injections per year. We believe Tethadur could be extremely important in creating the next wave of product to deliver these biologics to the eye on a sustained basis.
The use of Tethadur in certain ophthalmic applications is being evaluated under funded evaluation agreement with a leading global biopharmaceutical company. Other major pharmaceutical companies are evaluating our technology platforms in other ophthalmic indications under funded agreements.
We are continuing to invest in collaborations and partnerships as part of our strategy. Even as we move to a specialty pharma model developing our own products. There are several reasons for this. First, collaborations provide us with leverage. It can be preferable for a small company like us to team up with a large potential big pharma partner to take on another big pharma competitor no matter how good our technology maybe.
Yes, It is early. But while the retail traders were all wrapped up in Iluvien, pSivida was working hard on everything but Iluvien. Medidur is in PIII trial and they're not designing new drugs for that polyimide platform. It's all about Tethadur going forward. The evaluation agreements are for biologic delivery. So, to somewhat disagree with you, there has been a lot going on behind the scenes. If we can deliver biologic's......the whole world will be watching. In ending, this is a delivery system to deliver drugs, not a drug, now it's just an efficacy issue as they're delivered. Ashton wouldn't present data unless there is something substantive. Anything in biologic delivery would be exactly that. JMO
For those long PSDV, Tethadur represents the potential for Biologic delivery that'll put this company on the map. Avid Research's article at Seeking Alpha, stated that this data may be presented by the end of 13'. This data may reflect the work PSDV's been doing with the "undisclosed"global pharma. For PSDV longs, this is data long anticipated, and as I expect, to be very good news:
Tethadur is nanostructured porous silicon that is biodegradable. pSivida can control the size of the pores making it suitable for delivery of proteins, peptides and antibodies. Tethadur has been in development for several years but it is worth paying close attention now since it is in final pre-clinical stages (slide 4). Below is a slide with pre-clinical data of Lucentis using Tethadur technology. One of the 2013 milestones listed by pSivida in the June investor presentation is to release "pre-clinical peptide and protein delivery data." So, I expect additional Tethadur pre-clinical data later this year.
unwise, It's nice to see the MB getting back to normal. We'll still see some of the shorts around once in awhile. Good for you picking up the $2.33. Thanks should go to the shorts for making it all possible. I'm back accumulating too.
Don't take my word for it, although I've been saying it for almost too long. But here is the statement from the horses mouth. I would like to point out the "Delivery Processes" here, it just may apply to PSDV; in a big way:
There has been a big rush towards biologics manufacturing as drugmakers prepare for the new drugs that are becoming a larger piece of their portfolios. Swiss drugmaker Roche ($RHHBY) says it has 39 biologics in development. But while other companies are doing this piecemeal, Roche is rolling out a comprehensive expansion for large-molecule drugs and their delivery processes, investing 800 million Swiss francs ($881.8 million) to boost its production in three countries including the U.S. The buildup will also mean 500 new jobs over the next 5 years.
"As the world's largest supplier of biologics, Roche is committed to making the necessary investments to ensure ongoing supply of these medicines at the highest quality standards," Daniel O'Day, chief operating officer of the pharmaceuticals division, said Monday
I know it's hard to reach out and catch the falling knife, but when news about Tethadur comes out as a choice by a big pharma to platform their biologic drug delivery, it should move the company to a different level to say the least. Then, you can put a zero on this company's SP.
Regeneron posted upbeat earnings this morning largely due to its blockbuster eye drug Eylea. Lucentis is lagging a bit in sales, which is why I believe Roche is the "Global" pharma looking to PSDV for sustained release of Lucentis. "IF", we can assist Roche in competing with Eylea on efficacy with a 4-6 month sustained delivery of Lucentis (hello, Tethadur).......patients will quickly have a change of heart on which drug they prefer.
Some other quarterly reports this season have given some hints on the performance of Eylea, Regeneron's treatment for age-related vision loss. European marketing partner Bayer (BAYRY) reported last week that its cut of Eylea's sales rose 16% over the second quarter, when it was launched in Europe. RBC Capital Markets analyst Adnan Butt wrote in a research note that the $115 million in Q3 sales topped analysts' consensus of $106 million.
Butt also saw positive signs in Roche's (RHHBY) comments earlier this month about Lucentis, the Eylea rival that Roche co-markets with Novartis (NVS). Roche said Lucentis uptake was strong for its newer indication of diabetic macular edema (DME), and that Roche expects to get competition on this front from Eylea in mid-2014. Butt wrote that this is ahead of his expected timeline for Regeneron's own filing for a DME indication, but that when it does come out its uptake pattern will probably mimic Lucentis'.
The blockbuster launch of Eylea over the last two years has sent Regeneron stock on a bull run that peaked at 319.83 on Sept. 30. In midday trading in the stock market Monday, Regeneron was down 1%, near 283.
I'm watching to pick up more shares on a big dip.....but there seems to be support at around $2.50. We're all waiting for news on Tethadur and perhaps some POC/Latanoprost data. News on this level can push the pps much higher. Volume is subtly good for post Iluvien CRL. Remember longs, PSDV has moved so far beyond the Polyimide tubes to deliver a steroid. We're all now waiting for news regarding data on Tethadur, this could possibly be the most widely used platform for sustained release for biologics in medicine. It'll make Iluvien seem trite.
Slick, after the CRL it seems we're all taking a breather. I've been posting for many years. This POC is a valid question and many longs have often wondered the very same question. Between you and me and this board, it does seem it's about Tethadur and it's relevance. We will soon know whether this is a company worth 100M or 500M. I'm not going to pound the facts why it should be rated one way or the other. You, however must wait for the data from management. I am looking for comfort much as you are.
JD, I'm slipping away until the Tethadur agreement, which I feel is on the horizon. Don't sell a share, but collect a few if you can. You've heard the phrase "buy low"... I'll leave it at that. Be well, and when the good news comes, the shorts will be paying for dinner.
PFE owns 7% of outstanding shares. Look at key statistics in Yahoo finance page/PSDV. Roche is presumed to be a potential buyer due to PSDV's pre-clinical data with Tethadur, showing very strong results in sustained release of Roche drugs; Lucentis, Avastin and the breast cancer drug Herceptin. Sustained release (6 months) and bioerodible formats a very important factor in gaining market share against Eylea(REGN's veg-F) These drugs get injected every month without a sustained release platform.
Bourbon, It has been my thesis that Roche has the global evaluation agreement for Tethadur in the eye space. All PSDV's pre-clinical work is with Roche drugs/ It's been ongoing for more than a year. Tethadur will provide sustained release and therefore competition against Eylea( REGN's veg-f) and plenty of it. It's all about sustained release for biologics and PSDV's Tethadur will be the global leader. It is bio compatible.
Next week, they'll have enough cheap shares to buy out the company. They knew they'd get to raid the kitchen on an Iluvien thumbs down. Looks like they did.
Let's see. 4 Million Shares traded today........2 M. tomorrow.....get it?
Roche needs to compete with REGN's Eylea. Roche "NEEDS" a bioerodble
sustained delivery system that lasts 6 months. Lucentis/Avastin will take over market
share from Eylea.....simple as that. PSDV has the Platform in Tethadur.
It was good to have you around all these years. Take care if you are moving on. I've enjoyed the company. Check back in every once in awhile. As for writing more on this MB; going to take a big break and just watch. Be good.
You can't make sellers understand. All they see is an Iluvien CRL, now they're out and the new owners are in for obvious reasons. There is a sale today. If they didn't do their own DD, it's there own fault.
Mo, You know me. PSDV shares were inexpensive at $5. I've been a long time holder like you. I bought heavily at the low 1's, like you did, and traded up to the 5's, like I'm sure you did. Mo, you know Tethadur is about to come out of the closet. Roche is sucking up shares today on the BIG CHEAP. It's fricken nuts, I've never owned this stock for "ILUVIEN". By the end of this year, we'll know the truth.
You guys don't get it. Retail traders are giving shares away. You should be buying, not selling. I know it's hard to see, but Biologic delivery is what PSDV will be doing going forward. Roche is picking up shares right now, that they won't have to pay handsomely for later.