Kathleen Sebelius has nothing to do with FDA.
You need to look into the Margaret A. Hamburg FDA Commissioner and her Hedge fund husband.
Congress confirmed her without asking her and her husband to divest their investments so shame on both Dems and Republicans. No one ever looked into her and his portfolios for conflict of interest. Shame on Obama for proposing her in the first place without forcing her to sign conflict of interest wavier.
Google Margaret Hamburg and conflict of interest and watch some videos and see read somethings and you will be better informed.
Finally search and read fdas-hamburg-husband-have-health-related-wealth it is a WSJ piece.
Its like Obama's birth certificate or his college records - if there is nothing to hide why not show it for what it is? As soon as you become a public figure you chose to do so, you also chose to give up a private life. Same applies to Romney who refused to disclose his tax returns. Why play games? Was he ashamed of how much money he was making? Or was it because he did not want to disclose how much money he made from which employers whose boards he sat on?
Take the politicians, lock them in a room with the Talibans and throw away the keys.
It stinks so something might be fishy.
Basically the corrupt FDA officials have allowed REGN to introduce their drug in US before Iluvien.
Someone should go to jail on corruption charges wish this was like China. I have seen this so often when a smaller companies products are delayed without reason or merrit on the "whims" of FDA and the guise of "scientific" data and the same agency approves the drugs one or more years later on the same data. Reason for the CRL seemed to justify a delay in approval for the competition to catch up.
FDA should be shut down, I agree with Ron Paul (he is a joke), but FDA does more harm than good, they delay drugs, increase the costs, and their justification is without merit. If they are doing a wonderful job, why are drugs taken off market after approvals - if they are doing their jobs diligently nothing should be missed and riskier drugs should never be allowed in the market place but they are allowed to pick and chose the winners for us - it is a rigged market.
Am I supposed to be happy and thrilled with the PDUFA news? Stock price reflects my sentiments.
I am guessing the PR was hollow and the Co. did not discuss or disclose any pre-clinical data for Tethadur basically same old bs.
News was #$%$ and expected anyway. Nothing new and now we know the response will come by Sept. and PDUFA date may be Oct as expected. FDA just delayed everything by a year, thank you and hope those who are manipulating biotech stocks from the inside are benefiting big - high risk high rewards. Risk is a long vacation in prison, we all know the rewards. Ethics and conflict of interest never mattered to some departments.
Make antisense of it. PSDV will move on Tethadur provided the mgmt ever gets around to publishing any news related to the product. Maybe they are pulling the wool....
What differentiates champions from participants is how long some event takes place and what they do in the meantime. Months go by without any positive news and the stock is boring as hell. Lot of promise and nothing to show for it. I do not blame Bev - he is first of all a third party, he relies on information that is provided to him. He is not making up stories or painting a rosy picture either. Problem is the Mgmt is ultra conservative and they think they have all the time in the world to act. Problem is the market place remains dynamic and competitive so it will hurt investors. Mgmt needs to get aggressive with deadlines and deliverable, too complacent for my taste..
Speaking of which where is the data? Enough already.
Roche/Herceptin is being pushed for approval in US using SC route. From a scientific and patient convenience POV long duration sustained delivery products seem perfect a fit and a must have for all pharma companies, unfortunately the method in which payer/prescriber are paid there is no real incentive for either the payers or the prescribers to go long duration ssr products, IMO.
Payers are being paid mostly by Govt. programs for life threatening diseases including very expensive oncology products. Majority of the payments are made by Medicare/Medicaid (now Obamacare), FDA does not consider cost savings and relief for patients in the approval decision. Efficacy and safety are the only data considered, as a result it is easy for a large Cap pharma Co. to push a mediocre drug (in terms of efficacy) through the approval process. Once approved Medicaid and Medicare cannot usually deny reimbursements for the drugs and hospitals and prescribers are given billing codes by the Pharma Co. to bill the drug to the Medicare/Medicaid.
Given a drug is approved and is easily reimbursed Oncologists usually write Rx because they get nearly 7% of ASP as administrative costs. Hospitals and related staff can bill for the infusion cycles and everyone benefits except for the tax payers.
You need to look at drugs like Bexxar and Zevalin both failed, while Rituxan is a roaring success. Do your research and compare Rituxan vs Zevalin for first line therapy for NHL. Global sales for Zevalin I believe are under 20-25M. Zevalin costs 28K vs approx. 250K for Rituxan per patient. Now figure the ~7% ASP for the Oncologist and wonder why the better drug failed. We live in a corrupt society where big business and deep pockets are calling all the shots and tax payers are the suckers who are left with the bills. Oncologists are unethical greedy bums who will do what it takes to earn more over what is best choice for their patients.
Tethadur has a place in the market, but
I agree, the only issues for me are as follows:
a) How much are we giving away?
b) is the sales force going to be effective in marketing the product.
Two issues come to mind - one if the comp is based on the % sales growth and commissions the sales reps are likely to be eager to detail the drug more often. However, they do not make the Call Plans, they do not decide which Doc to call and which products to detail and in what order - home office does. So, if Quintiles is not making a big buck on Illuvien they would detail the product but not bump it up on the detail order.
At this point all we are debating is #$%$ and meaningless frankly. It all depends on the contract signed by the two parties involved and if and how many dedicated reps are assigned etc. Without knowing any details I can take a cautious stand and others here can blow the trumpet and sing and dance and do the victory lap. Results in 2 qtrs will show and Alimera insiders will be churning based on the sales force performance.
I wish it was in US because there is a way to track the sales force pulse, in EU I have no clue. I will still wait and watch. To me anyway it is chicken feed what pSi gets from Alimera in royalties from EU or even US for that matter. Milestone payment matters and Uveitis and Tethadur matter.
If I was managing pSi, I would have a good idea on what to expect in terms of sales in EU. Do a deal with a finance Co. and get upfront payment for the next 10 years of sales of Iluvien in EU minus whatever discount, these deals are done on tiered revenue so we would still participate in upside surprises but it would make not difference Q/Q in terms of what is actually earned from Alimera's business. Even if the drug completely fails, pSi would be sitting pretty on whatever cash deal they do.
You might be 100% on target with OGXI - the issue is the short interest or lack of is interesting to observe. Go back and look at your screen and see what was the short interest on those 26 Companies and compare that with OGXI.
You might be right, Isis has not been very successful in bringing their drugs to market. Mipomersen was a fluke? I dont know - long time coming. Isis burned over 10Billion over the past 30 years and got 2 drugs to approval. Today everyone is no their bandwagon and the market cap is sky high and possibly the thought is the 25 drugs in their pipeline are likely to get approval . Oncogenex sublicesed Isis drugs, there was promise in these drugs but the ramp up and trials has been too slow. Oncogenix should have brought this PIII data to the regulators some 4 years ago, not licensed to Teva for peanuts - but all that is history we are where we are, the drug will be an also ran and may make 400M in peak sales. If it gets approved you can expect 3x the current market cap, if not it will go back to $4-6 range and languish until the next PIII trial. Do not write off the Co. on one failure they can survive a failure. I am still kicking myself for dumping Onyx Pharma after Head and Neck failure and selling in the low $3s.
In the meantime - you might be right but show me the short interest - there is about 80M to be made on the short side on this trade but I do not see any interest. I have option orders open on both sides and nothing no takers - spreads are too high. Tells the stock is not on smart money radar. Less than 10% institutional money is another indicator.
No one seems to care if it will or will not get approval.
Looks like Alimera threw in the towel and contracted a sales force to market the drug for them. License the drug from someone and contract someone else to market the drug - way to go. Small pie getting smaller is my reaction. Short term it may sound good because there may be a ramp up in sales but longer term how much is Alimera giving away is to be seen. Quintiles could possibly be getting 30% for their efforts. Essentially the $5500-$8500 number just shrunk to about $4000 avg. selling price. Quick get the calculators and start multiplying with the patient population derive the revenue and figure out the share price........
Put some more lipstick on the pig. Alimera just proved they do not know how to market the drug, do not have the resources and it was not a successful launch, still not bad to admit your failure and give the mandate to someone else - I just hope it does not languish on the back burner of Quintiles Sales Reps and it is not going to be a tier 4 product to detail - "oh Doc, how are we doing on time? If you still have time I would like to discuss this phenomenal product Iluvien...., if not we can discuss next time we meet which is say 60 days from now?" Unless they actually target the Doc specifically for Illuvien there is no way you get a big bang for the buck marketing the drug. If anyone here understands how SFA systems work and how docs are "quintiled" you will see the # of docs to call and whom to call is based on a specific drug, the rest of the drugs detailed in that visit are evenly distributed - not necessarily targeted. You may call a Doc who is not sold on the idea of Illuvien and will never prescribe it or you might over call on a 1st Quintile Doc who does nothing but recommend Illuvien- the middle of the bell curve is missed because you did not target Docs specifically for Illuvien. Anyone think otherwise must think, Quintiles is not going to dedicate 100 or more reps specifically for Illuvien marketing.
If there is nothing wrong why would the a public official in a key position not required to divest their investments?
Why are there boutique research firms which often doing illegal activities for large cap financial power houses? And no one is ever prosecuted?
Big money and large stakes compel large firms to do everything possible to safeguard their investments. Google Seattle Times "Selling Drug secrets".
I am not saying there was definitely something illegal done, but there is a possibility and I have doubts, because there is a possibility of conflict of interest. If I was the official in question, I would have divested just to rule out any doubts and possibilities - if you do not you subject yourself to all types of speculations.
I worked for the financial industry and I was forced to move my portfolio to fidelity, I had to get an OK to buy stock and was subject to holding requirements. I was not allowed to short sell and I was not allowed to speculate by way of options. Read CFA ethics requirements and then wonder why the right hand man of Buffet who was likely to replace Buffet (when he retired) was involved in an insider trading case but never prosecuted? It was Berkshire Hathway's shareholders money which was possibly lost - why was there never any action taken in that case? His resigning from the post is sufficient? Martha S. went to jail and gave up control of her Co. for life over 150K in gains/protected losses, the Berkshire guy gained 3M. It is not about the magnitude but even if I were to look at magnitude it does not make sense. Unless there was a lot to lose by prosecuting him the risk of him spilling the beans on everyone was possibly compelling.
Lower ranked foot employees are required to abide by the ethics laws but the large fish in the financial sector are spared? Even within the community there isn't a level playing field.
It is all a figment of my imagination - enjoy the rest of the day.
They will run the clock, if you have not got used to the idea you should learn to connect the dots.
FDA has successfully delayed Alim and pSi for years.
FDA Chairwoman is married to a hedge fund CEO making 120M/year in sal and comp.
One of the Top 10 investments of the hedge fund is in Regeneron
You really think the CRLs had nothing to do with a need to delay the drug as much as possible?
Go research everything and wonder why an important post in the Govt. agency which is one of the most lucrative and influential posts in the highly speculative business was not asked to divest investments prior to confirmation and/or why someone with very high conflict of interest was allowed to be confirmed for that post?
I tried posting earlier with the urls for every one of these facts but Yahoo has its ideas on urls. Do your on DD and figure out why there is some merit to my line of thinking. I am tired of these Govt agencies manipulating and large financial houses stealing money from small investors like us.
Whatever I expect FDA to run the freaking clock on ALIM. ALIM and PSDV also know this but no one will confirm it for you.
You seem to be too sure about pSi only game in town for injected, timed released silica. Maybe you are right to a certain extent for Ophthalmology but a lot of us are here for beyond Ophthalmology. I am not saying Optho is not lucrative, but the true value of Tethadur is in the Onco, Inflammation & Infectious, Autoimmune and Metabolic areas. It does get competitive, you should research si and non-si based porous sustained delivery systems, nano structures delivery systems etc. Read some research papers there are over 200 on the subject and you will see it is highly competitive area, we are not the only game.
When it comes to biologics and patent extension for blockbuster Oncology products, look at alternatives like Halozyme's technology as well. There are various ways to extend the life of a drug, Tethadur is one mechanism.
My only concern is everyone is reading too much into the PR machine right now and I am not seeing anything from the Co. In the meantime there are some die hard bulls here who seem to think they know it all and think they have discovered something in pSi which is a game changer in the pharma world. I remain optimistic but I am a pragmatist. I want to see the Co, succeed just as the next guy here but I have been fooled way too many times in this business and I need to see some partners lay some serious cash on the table for Tethadur and fast. Long before I start to count the chicks in the meantime, while there are others on the board who seem to be jumping on every statement issued by the Co. or its PR machine and are ready with cork screws in their hands waiting to pop open the bubblies....I just have to tell them baba - stop dreaming.
Show me the MONEY- Show me the MONEY, show me the money, show me the money.
Designing a good product or even a great product is 1/2 the battle. Timing to market is more important, if you know the story of MSFT, APPL and Xerox you will understand the difference, I hope. It is not about how great the product is, who gets there first. Remember the risk for a microcap like pSivida is IP risk, larger Corporations with deeper pockets can infringe on their patents and mire a small Co. in IP litigation for years, challenge and re-challenge every aspect of the patent and eventually you will have a product in market which infringes, IP is weakened by the repeated challenges and changes to claims and the smaller Co. has little money and survival is a battle. Seen that too often so recognize speed to market is more important than being prudent and safe. Do not assume others are not working on similar technologies including Si so we are not the only game in town, IP risk is equally high given the $$$s involved.
Dr. Ashton may be doing a disservice to the shareholders by being ultraconservative for too long.
Make your bullish case now, but do not disregard the IP challenge issue without researching it.
I am thinking the worst case of 3 years for the product to be on the market. 2 yrs from now we should be in the face of FDA - FDA may take another 6-8 mos for approval and a Q after that for the product to be on the market.
I do see your point about Tethadur and partnerships, but given the information is sketchy and the CEO and others have discussed only one large bio-tech conducting an evaluation makes me think there is nothing else in the works.
I appreciate the slow and steady and a ultra conservative growth path, but it also translates into a slow growing Co. Please understand this is in relation to the % ownership of PSDV stock and we are discussing institutional interest in the Co.
In this crazy market thanks to easy money, money is chasing money and fast growing Cos. Popular and prudent belief is to limit dilution and not borrow too much money which may make sense in a tight monetary policy market. Currently when money is cheap, pSDV should raise the 19.5M or whatever ATM they have filed even if it implies they have to sell about 6-7M shares. Increase the burn rate from the current 2-3M/Q to about 10M/Qtr for the next 2-3 Qtrs but have several trials going to evaluate safety and efficacy of Tethadur platform and applications for several different indications.
Capital markets will value pSDV 10x-100x the current valuation if they have 4-5 PIIs going in areas like Oncology, immune system (auto immune - RA. lupus etc) and metabolic disorders (thyroid, diabetes etc). There is nothing to prevent pSDV to eventually get there and possibly have treatment options for several indications, but based on the current spend and interest in the platform the growth rate will likely remain slow for the next 4-5 years, I mean an explosive growth.
Haven't I heard that before about an undervalued stock before? I just hope they are all pleasant surprises, else it will be a bummer do you agree?
You seem to have too many issues
a) giant ego - you seem to think just because you go google everything "pSivida" you know more about the Co. then others do. Please tell me you have some inside information in which case I will agree you know or have the ability to know more than the rest of us, until then just tone down what you think you know. About your knowledge of the technology, MOA or anything related to pharmacology, pharmacokinetics or pharmacodynamics or to that matter material science and nanotechnology please do not assume you know more than others. Even the CEO of pSivida or the chief scientific officer of the Co. does not know it all so take a hike if you think you understand how exactly all drugs will behave when delivered via tethadur or similar. In theory it is nice and it will work, but that is why clinical trials are required. Just because the Co. or its officers say so, does not mean it works. 90% of the PRs related to PIIs are exceptional in safety and efficacy, 90% of the same drugs fail in PIIIs and are not approved.
b) Let us not boast about who's #$%$ is longer in terms of who has more shares of the Co. Again you have no clue who owns what and how much here. Just because you have been here for a while and may have a lower cost basis does not imply anything.
c) Finally, what I or anyone else does with regards to trading decision related to pSDV is not your concern.
So, having said that - tone down and respect others and their opinions, just as they do yours.
Do not know what you are talking about. Shorts and longs are required to provide liquidity and support and resistance to stocks prices. Without the shorts this will never move up like a bullet, I hope the short interest rises. Problem with pSivida is the management is too passive and the secondary filing was done too prematurely. It is like a PME - management did not know how to wait for the climax and came out too early with the secondary offering.
I hate non-earnings news releases where there is nothing new to focus on except for dilution. I expect a good deal of discussion around the secondary offering and the timing of the filing. It makes no sense for pSivida to raise cash at this stage given Alimera is doing it for pSDV. Will see, I will hate the next week.
Where is the news about partner trials? Hush and mum is the word?