JD, I think you're right about the pending announcements regarding Tethadur. There has been nothing said by the company regarding the evaluation agreements. Our time horizon for the company to announce animal data is maturing with this year ending. I'm very comfortable with what I believe will be very positive news. I'm also expecting an NDA to be filed by pSivida, on their own, this fits in with their "specialty Pharma" model they've been discussing for about a year. My questions are with what drugs and for what indications. Perhaps out of the eye space is a real possibility. I know that everyone is focused on Iluvien and rightly so, but the Tethadur news should be trickling out by years end and becoming another real focus for investors. The animal data is due this month sometime. Hopefully, with Iluvien's positive nod and Tethadur making strides we'll get some mojo going. This valuation is goofy low for a company that might carry the biologics forward for big pharma.
Let's face it, owning stock in this company has been tough through the years. We've all got
baskets of disappointment with the Iluvien CRL drama. There is still one more basket of potential disappointment that may follow. I hope for Tom's sake and the assortment of all other longs here that pSivida actually gives us some "beef" soon. Let's hope the Tethadur data creates a mild interest for taking it into the clinical setting. We'll all be reconsidering our positions in the event something doesn't happen by years end. Too much hope, not enough activity in a field that is all about moving forward.
JD, He'd be considered a beneficial holder, which is greater than 5% ownership. If he were to acquire more shares he'd have 15 days to announce it with a form 13. If you went to RA Capital holding you'd watch for any form 13's in any of their holdings. Obviously, he just posted one with the ACHN sale. He owned more than 22% of ACHN and it moved big in the last month.
I'm watching to see how he re-allocates those dollars. He owns some of the most promising biotechs. His capital management is stellar in his hedge fund. He also owns 8.5% of pSivida.
Vin, Yes is the answer to your question. If the devise you're referring to is pSivida's protein delivery platform- Tethadur. That's what the excitement is about here on the MB regarding the company. You can contact Beverly at IR/PSDV, she can potentially update you with the latest releases. There are very few, if any, protein/antibody delivery platforms to carry drugs and sustain release them, especially in the eye space.
There is no question that is has to be "proven in PIII trial". You are correct in that it will be more expensive if Iluvien is not approved. Iluvien should be approved and one trial for Medidur Uveitis will be all that's needed. Now we wait....that's nothing new for either one of us. That's what we've been doing all these years.
Remember everyone....Medidur for Uveitis by pSIvida is better than already FDA approved Retisert, by PSDV. The side effect profile of Medidur is much better than Retisert with the same drug (Fa). The current end point of the phase III trial is "recurrence of the disease", not vision letter improvement, as with DME. Yet, there might be vision improvement (added benefit). Medidur for Uveitis and the current PIII trial will be able to reference the entire "FAME" data of Iluvien. It belongs equally to pSivida. DME and Uveitis are completely different indications and have completely different end points in their respective PIII trials. Therefore, Medidur is not "DEAD" in the water if Iluvien is shot down by the FDA. "IF" the FDA approves Iluvien, then pSivida can file an sNDA with one completed trial having achieved the the end point of "no recurrence of the disease".
It's going to save a bunch of money and a bit of time. The FDA naturally knows about this trial and how important it is to get Medidur to market. So why did they twiddle their thumbs on Iluvien....? To get the anti vegf's going first? I think so.
You also have to remember that Roche is huge into diagnostics. The abstract from which this was taken is 4 years old. I'm sure pSivida is well aware of all the implications. Now, you tell me how does this compare to lluvien's potential? Releasing Fa for 3 years is big and it will find a market. But, it's nothing compared to the vast nature of Biosilicon and all it's products and potential. Rabbit testing with biosilicon has been tested for 10 years. Trust me, pSivida knows as do those evaluating the technology how things are progressing. As this abstract suggests, progress is easily monitored by light spectrum in vivo. That's the beauty of it. When pSivida releases data, they've known from insertion how drugs are working and whether there is toxicity. It's fairly well known that biosilicon is very well tolerated. You're correct, I believe, that those who control this technology will control a big part of sustained release going forward.
Here is just a taste of what's ahead for pSivida, and why they'll get some street credibility real soon. Can you say big pharma?
10. Future Trends
pSi has shown its superiority in a wide range of techno- logical applications over the last 50 years. More recently Si nanoparticles have been proposed for applications in biomedical and pharmaceutical fields as drug delivery and sensing systems. The simplicity of its fabrication and surfacemodification methods, its low cytotoxicity and its optical properties have put these at the forefront of implantable drug delivery devices . The optical properties of porous Si provides an advantage over other nanoparticles, since these can be detected in vivo with imaging techniques, without the need for a label. Furthermore, its optical reflectivity can be used for the development of sensing devices. In fact, Si has been used extensively for electronics and micro- and nano- chips have been fabricated for biosensign applications [80, 132, 180]. Biocompatibility issues with the biorecognition molecule and the metals of some of the components of the sensors are currently slowing down the implementation of this in vivo. Membranes that impart permeability and decrease biofouling of the electrodes are investigated and porous Si provides again an interesting solution [181, 182]. Microfluidic devices to deliver small volumes of fluids have also seen the advantageous properties of porous Si . Aptamer-incorporated nanoparticles have been envisioned as delivery systems where the drug release is controlled via aptamer molecular gates . With the advance of science and technology, closed-loop systems are seen as the next gen- eration of therapeutic devices, where sensing mechanisms would trigger and control the release of the drug at a specific site or when reaching a certain threshold.
The diversity of pSi allows the combination of microflu- idics, microarray biosensors, drug delivery , and high- resolution imaging techniques
Yeah, I kind of agree. But you've got to do what you feel is right here. We've been wrong before and it hurts when we're wrong. Good luck bud.
JD, I'm not thinking about that too much. I think you mentioned something like $2.50ish in an earlier post. You might be close there. I'll jump in on that too. If you're concerned you could lighten up on some of your shares into the run up.
JD. I think Hernando is right on several things. However, I will jump all over pSivida at $1.50.... and I have a large position already . It's not going there regardless of what happens to Iluvien. The scarcity value of Tethadur will give this company a foothold for years to come. A license agreement will bring validity to the Tethadur platform. All the waiting will soon bring some clarity. Remember that biosilicon in the eye can be monitored and evaluated within the light spectrum. pSivida and their big pharma partners already know how drugs are being distributed in the eye. They know the range of toxicity, if any, and they can monitor rates which are size dependent. I think the Iluvien decision will assist in establishing a value for the company. And like the other Dr. Paul, I believe, as I always have that pSivida gets acquired. The platform will have to move quickly as time is more of the essence than ever for Roche and their biologics.
The other Dr. Paul that wrote the SA article was on target on many things. Larry Smith was too when they both mentioned the nature of how the sp might move on an agreement to take Tethadur into the clinic. For those of you who have held a position in pSivida, it might be tempting to pull the trigger to sell some shares on the Iluvien run up, which seems to once again be materializing. Looking back it's pretty clear letting go of shares on two prior CRL's would have been a smart play. However, with the possibility that Roche may bite on a license agreement with pSivida to take Tethadur into the clinic, it's just one really big reason to hold
through the Iluvien PDUFA date and the news stream that may accompany it. I think this company has the technology to go a long way with biologics. I loved the way the SA article pointed to "scarcity value" for Tethadur. Great way to put it.
JD, Always hard to predict. I'm always surprised by the movement up and down. If an investor plans to take some shares off the table, it's always hard to say when. Naturally, when one looks back, it's real easy to say. Good luck. It looks like the latest SA article has started some volume activity and sp movement to the upside.
Hernando, You're right here. I've been totally amazed by the FDA moves regarding Iluvien. It's down right manipulative. Especially watching the sp the day of the last PDUFA date. You may recall the volume moving unexpectedly downward. This was obvious knowledge as to the decision ahead of time by the sellers. It will most likely happen again, up or down.
JD, I read the article just now and was very impressed. I'm still not sure Tethadur can deliver biologics for two years, but who knows, maybe they can. This bullish case has been much like mine. I'm just glad to see someone else with street cred delivering the news. Well done. As you know, Yahoo doesn't show SA articles anymore. Thanks for bringing it to our attention. I'm sending the article to others who are interested in emerging biotech's.