JD, It's OK, your brain has been busy with its effort to evaluate the promise of this company, you're doing great.
Derek, Don't mind any of it. Just give us a break. Those that post on this board have been doing it for a long time, we've all been thrown under the bus so much, it's now like a warm blanket. Come what may regarding the FDA decision, many longs will continue to hold for that which evolves regarding Tethadur. Thanks for being honest and upfront.
DJ, This company is the real deal. Iluvien as a product was completed long before the first CRL on 11/11/11. If you're familiar with pSivida's pipeline , it might be worthwhile to hold a bit longer.....regardless of the FDA decision. As always, it might be a bumpy ride. But look to the existing holders of beneficial interest, it's keeping me here just watching that none of them are selling......they're adding.....i.e. RA Capital.
Tro, I thought we just saw a sign of them with Love_Bio.....he's so pure isn't he? This is a broken fricken' record isn't it? Let's hope by years end Paul Ashton gives us train wrecks something to really chew on.
Terry, Funny. If Roche doesn't acquire the companies that assist them in product development , it therefore becomes necessary to split their revenue streams with those that can help. I still have a suspicious feeling that not only is Roche in on the tech evaluations, but that after the Iluvien decision and before the end of the year pSivida signs a license deal or gets acquired. Biologic delivery backed by a profit share with Iluvien= $850Million. This sp is getting pushed around because half the ownership is retailers. I'm one of them but just keep holding my low basis shares.
Been around 4 years Derek. So, yeah, 3 CRL's are hard on the headset. Many longs on this MB realize that Iluvien is a big deal, yet many also believe the pipeline is about to get going on Tethadur, our biologic platform. So if you ask me about approval, I'd say pretty much for sure this time with the label restrictions.......but I have said that before. I'm long on the biologic delivery pipeline, so it's a tough call if you're a trader. I just hate the newbies on the MB like the ones' we've seen lately. Longs on this MB are very well informed and have very thick skin.
Vero, I guess you're noticing the new pumpers to the MB. What a bunch of Dooshe's. Where were they last year when the rug got yanked by the FDA? I'm just calling them as I see them. Good Luck Vero
Master-baiter.......you and Love_Bio and are in this together? Give us a break please. Out of nowhere.......here you are? Not. Team Doosh for sure.
C'mon man. This board is full of old time longs. You show up and start pumping, pumping and pumping. Who are you trying to fool? Slow down there big dog....You'll be gone next week anyway with your $200 profit. What a doosh.
Well Terry, It's certainly one we've become accustomed to. The shorts have always been quick winners in pSivida. Regardless of Iluvien we have to look at the pipeline, which is now on the threshold of showing it's promise. I'm a holder through all the Iluvien, Dan Myers stuff. It will be nice to get resolution out of it either way. I would like to see shorts flop around in their own feces for a couple of weeks, wouldn't you?
We never know what the heck they're up to. But it does look like when a stock is thinly traded , such as we are, we are subject to moves like this. Nobody said it was going to be easy . I'm picking up a few more this week.
Terry, It's now all about the money don't you think? How long have we been saying that. Looks like a niche for pSivida, making drugs as effective but lasting a lot longer. Sounds like the MPG scenario
I know everyone is freaked about the FDA PDUFA. The whole thing has been a nightmare through the years. The 25M will be nice......because this is how pSivida will be spending it:
Develop Sustained Delivery of Off-Patent Drugs and Biologics. Many drugs and biologics either are now or will soon be off-patent. It is estimated that over the next 7 years patent coverage will end on products with world-wide sales aggregating over $50 billion annually. We plan to use our technology platforms to develop products using off-patent and generic drugs and biologics with a significant market opportunity where less frequent dosing through sustained delivery and/or release at the treatment site through targeted delivery would materially improve the effectiveness or convenience of the original drugs or biologics. We are optimistic that our Tethadur technology can provide sustained delivery of large biologic molecules, which currently cannot be effectively delivered by other sustained delivery technologies. By focusing on delivery of already-approved drugs and biologics, particularly those requiring shorter clinical trials, we believe we can minimize the risks and financial investment required for product approval.
In reading about him, he seems to head his head on straight; just like everyone on this MB.
In accordance with pSivida's current non-executive director compensatory arrangements, Dr. Barry received an initial grant, subject to shareholder approval, of an option to purchase 40,000 shares of pSivida Corp. common stock at $4.77 per share, which becomes exercisable in three equal portions on the first, second and third anniversaries of the date of grant and remains exercisable thereafter until the tenth anniversary of the date of grant.
Terry, The evaluation agreement must have been announced more than a couple of years ago too. I remember having to look it up myself. I do recall hearing Ashton talk about the arthritis end of sustained delivery. One more case of not much said from the company, but the systemic end of Durasert and/or Tethadur is obviously of big interest to pSivida as well as big pharma looking for sustained release platforms. I just want to see what drug is going into the clinic. The implications will follow. I guess HSS is a great facility.
Vero, That's what I picked up. We do know that Lucentis is loosing market share to Eylea, and now it's approved for DME. I still think Terry and Tom are on target with all DME patients becoming Chronic, so Iluvien will find a cozy spot with retina specialists with 3 years worth of sustained release. But, getting back to biologic delivery.....we just won't know how things play out until they do, but there is a lot of pressure on Roche to compete with Eylea. So, how are they going to do it? Well sustained release can change that in a big way. With animal data pending, Paul Ashton will build the hypothesis that it will work for humans in the eye space and systemically. There will be a lot more clarity for a lot of things after the PDUFA date. I was surprised at the amount of information Ashton provided in the CC right before the PDUFA date. Good luck
JD, Hospital for Special surgery is one of the premier hospitals for sports medicine in the east. pSivida signed an evaluation agreement several years ago. You can still Google it and it should come up.
Now then, wouldn't that imply an agreement with the drug company that owns all the rights to that drug? Lucentis-Roche/Genentech? Yes it would. pSivida won't just do it on their own without one.........Now, osteoarthritis clinical trial. Could this be the work that pSivida has been doing with HSS from the evaluation agreement 3 years ago. Yes it could. No big market for sustained release drugs in arthritis is there? pSivida may not say much until there is something to say. I think they just said it.
Sentiment: Strong Buy