Fan, If you've not heard of 505(b)(2) route, do google it. This just may be the route that big pharma uses to severely shorten the regulatory route for Tethadur. Remember, these drugs are very well understood. When Paul talks about "no new chemical entity risk", this is I believe he's referring to. Additionally, the "breakthrough" designation may apply as well. The biosilicon platform has a track history in the pancreatic trials, through PII. It was very well tolerated. I think the FDA is going to find room for this platform in a big way, as it's so broad in it's spectrum and application. Either way, both of these avenues may only take "ONE" trial and could be done in 30 months ( 505(b)(2) )
Guys, You all know how Paul speaks. He's almost giddy in the CC, if you could ever say Paul is giddy. I just think that Tethadur has made some progress lately, at least enough to where Paul is comfortable with statements like these. He might also be getting some hits on the bio better front with big pharma. At some point this company should be garnering more attention, don't you all think?
Kool. I do too. Right now we are a shadow of Alimera's success or failure. That just isn't right. But, until we show independence with our pipeline, that's the way it'll stay. Tethadur data should enlighten the masses, including big pharma. They'll know they have to lock up the science or get in line. I see a license deal before the data is out. That means by July 1st. I can certainly wait that long, and I do think the stock should move favorably. This will be in concert with Iluvien finally getting it's legs in the US too. This shouldn't hurt either.
Folks, I think it's right around the corner, and I've personally waited years for these statements to come from Paul Ashton. Now that things like this are being said, it speaks volumes as to the confidence our CEO has about the platform. Remember, this is big time multi billion dollar companies and their prized, profit producing drugs. They don't want to pay a cent for something that isn't "bio-better"... this is from Paul on the transcript:
We think there could be potentially a huge number of applications of Tethadur. The partnering would also provide us with leverage to give us applications we otherwise wouldn’t have the resources or bandwidth to pursue. Also via partnering we will continue to evolve our technology platform and apply what we have learned to our own products. And of course partnering can provide critical financing for our own development work.
Tide, Thanks. I do think your time horizon on PSDV should be at least 6 months. We are on the threshold with the pipeline, which is "NOT" priced in. Then again, neither is Iluvien US. pSivida's Tethadur platform is the one to watch. Do read the transcript that is just out. Paul Ashton is not one to embellish or get too creative with his animation. This is the real deal, big pharma is watching it much more closely. You did pick a good one.
Yep, Data of Tethadur sometime mid year. That's huge for me, and that's what I wanted to hear in the CC. Plus, the data may include that from out of the eye space. IM, Sub-Q, etc. Imagine the drugs. So, does that mean the evaluation agreements with big pharma are curious about application outside the eye space for Tethadur? You're damn right they are! Dr. Ashton is generally stoic by nature. He's very animated when talking about biologic delivery in recent CC's; he knows how big it could be. So do the rest of us.
Tide, The trial will complete enrollment sometime this summer. There should be data available by fall. Remember, the investigator sponsored study showed real efficacy for Medidur Uveitis. It is very much expected that the ongoing PIII will show very similar efficacy. If Iluvien US for DME gets approved it should limit the Uveitis trial to one, instead of the two (originally planned). That would save 10M
Terry, I've been reading a bunch of abstracts. Many cannot be copied and therefore are difficult to paste on the MB. The world has known about pSi nano for some years now. PSDV will be the company moving it forward commercially, and profitably. The coatings are what I don't understand yet. I'm really looking forward to the next couple of years. Thanks for coming out of the closet.
Mo, I've been harping on Beverly for information regarding Tethadur data release. Paul tells her mid year at the latest. In all of Paul's presentations lately he's said that pre-clinical data is pending....so, when. I firmly believe pSivida is working on a license deal with big pharma, hence the time. pSivida has known how to deliver these proteins, and now that big pharma knows they'll get to release the data (granted, probably in Rabbits) to the world, then we'll all know....especially other big pharma. So, along with Iluvien US pending approval, I want to know that there is a date on which the world will get pre-clinical Tethadur data. There are those that might say; "well, it's just pre-clinical".....that would be true. But, if you notice the myriad of drugs that PSDV shows release rates on, in their own work from past independent work... imagine what they can do now when they're working for big pharma's own drugs. I bet they've gotten very, very good at it. The kicker here is this..."Can you get 6 month sustained release out of Lucentis or Eylea".....My gut says Yes.
Terry, It's so good to have the help you've provided this board. Many have been here for a very long time. As it turns out even I'm a newbee of sort, relative to Tom, Tro , Mo and as it turns out, you. Thanks for your recent involvement and positive contribution. I know IR appreciates the input and honest attempt to bring the PSDV technology within view of potential investors.
Yeah, Anti-everything, that's why nobody listens to you and you're downer BS. This is the most undervalued company in Biotech. What surprises Paul Ashton holds for stockholders going forward for the rest of 14', just might surprise even you.
Wow, you're the one with issues. I just present what I think are important things to consider that someone investing in this company might want to consider. Some of it is relevant. I've yet to see a post of yours do the same. I could care less about what you think.
Maybe you should just bail, or short the stock! What a winer. Also, there won't be any discussion about the secondary, it's an ATM.
I understand how PSDV trades. I've established a rather large position over the years. I also understand how it moves when it pops. A review of the 5 year graph tells the whole story. But, for people who are taking a position in this company, it may help to hear from people like myself and other longs, as to why it may fall 16% in a week. I also understand the secondary to be an ATM. This means that the management can "from time to time" raise capital when appropriate. To me, that means "when" good news is announced and the sp moves to where they feel "it's appropriate", they can sell shares at the market price. At the same time I will also agree that management is
very conservative, many times to the detriment of the stock price.
Shorts hope to scare you into selling by sending the price down. Then, they hope when it pops, you sell it, if you didn't on the dip. Either way, it's meant to make you feel like you shouldn't be holding the stock because of the volatility, it isn't easy either way. PSDV gets pushed around due to the fact that it's thinly traded. So, we're down 16% this week. Does that mean it's a bad company or investment? It's been this way for years. Someday soon we might trade on our own valuation and not directly correlated to ALIM, but for now.....
Tide, I have no idea what sp will do short term. I do think the company is set up pretty well for mid/late year moves. They could be good moves upward. PSDV gets knocked around pretty good some times. the last week or so is a good example. I think traders move it around knowing there are week holders, yet they jump right back in to cover if they're short. I've just held most of the shares lately, knowing that news could be right around the corner. Don't know if any of this helps. Good luck.
We all know that pSivida has Medidur for Uveitis in PIII trials, which investigator sponsored study showed to be very well received. It is now very possible that with Alimera very close to US Iluvien approval for CDME, that retina Doctors will be heading straight to Iluvien for the Uveitis indication via Alimera. We should be seeing data from the PIII trial for Uveitis by fall via pSivida, showing a very good risk/benefit profile for the indication. Even though the indication should on paper belong to PSDV, retina Doc's will reach for whatever works for Uveitis, especially if it works well, and it will. Still, good news for PSDV bottom line.
Good catch Terry. I have not seen this news. pSivida would not be mid to large cap, which make the invite even better. Keep up the good work.