What's Bad For Bisphosphonates Is Good For Emisphere [View article]
Yes the OARSI presentation was quite impressive. They published the results from the European Phase III OA study for the first time. I think that the drug will eventually be approved by the FDA and the EMA for OA. We missed the x-ray/joint space endpoint but the MRI proves that Oral Calcitonin is a disease modifying drug for OA with no real long term side effects. This is not retroactive subset analysis (rightfully squashed down by the FDA!) this is real science. The FDA already has admitted that the x-ray is a flawed endpoint and has announced its intention to migrate toward MRI but has not decided on specifics. Given that there are currently no decent treatment options for patients suffering from OA the FDA has to approve the drug in my opinion and to not do so would be unethical and a failure of their over-riding objective to help out patients. I can send you the publication if you leave your email in the comments section.
What's Bad For Bisphosphonates Is Good For Emisphere [View article]
I incorrectly stated that Amgen Prolia is a Bisphosphonate. My apologies. It does have some similarities to bisphosphonates, including some of the same side effects. saveourbones.com/proli.../
What's Bad For Bisphosphonates Is Good For Emisphere [View article]
I am going to OARSI in San Diego to get a feel for the buzz on Novartis/Nordic/Emisphere Oral Calcitonin for OA. I will try to give an update next week on my thoughts. Thanks for pointing it out!
What's Bad For Bisphosphonates Is Good For Emisphere [View article]
I have networked with some sharp scientists regarding the Tarsa/Unigene Oral Calcitonin and I have a couple thoughts:
1) They tried to go the risky, abbreviated route with a 505(b)(2) trial, skipping Phase I and Phase II. Because of this they don't have nearly as much data for the FDA and importantly not much safety data (which is also risky because of number 2) 2) I have heard from some scientists that their delivery technology inferior and their are talk that they pick up toxins and other drugs that the patient might be on and put them into the bloodstream. I am far from an expert on this so I don't have an opinion on whether this is true or not, but given that these opinions are out there more safety data would be better. 3) Even if they get approve going the shorter route their endpoint is weak. Novartis/Emisphere's Phase III Primary endpoint was reduction in fractures while Tarsa/Unigene's was increase in bone density. This would lead to a much inferior label for Tarsa/Unigene if approved. 4) Novartis had the exclusive license to use Unigene's Salmon Calcitonin manufacturing technology. They agreed to allow a sub-license to Tarsa. They would not cut their own throats so I am certain that they are making enough of a percent markup, or royalties that would keep Tarsa from dramatically undercutting them on price.
p.s. I probably should have brought this all up so thanks for pointing it out!
Great points emis_fan. I think that Novartis will file for and get approval in EMEA. With regards to the US trial I don't know which endpoint(s) was a concern for the DMC. Perhaps you are right and they were not trending toward efficacy on either pain or function, or is it possible that they were just not trending toward efficacy on JSN and the DMC gave their no reason to proceed recommendation just based on that (that would mean that in the EU trial they were trending toward hitting JSN in the interim look, but missed the mark at trial completion)? I will try and makes some calls and get some opinions on what the likely scenarios are.
I have heard that the FDA and the EMA are transitioning from X-rays to MRI's for OA trials, so even though we missed the JSN in Europe and possibly will in the US I don't believe that the claim of positively modifying the structure of the disease is dead. The FDA and the EMA have already shown signs of accepting MRI analysis and that is why it was included as a secondary endpoint. Maybe Novartis/Nordic foresaw X-rays as problematic from the get go? Such an interesting situation, right?
Great question emis_fan. The DMC are by no means experts on OA and they do not make judgment calls on the whether or not a drug is approvable. They are statisticians and they tell you whether or not you are trending towards hitting your endpoint(s), nothing more, nothing less. Therefore they would never concern themselves with FDA standards for approval. I hope this is helpful.
Sure Novartis will be chomping at the bit to either buy us outright or buy back the royalty stream for Calcitonin for OA and OP. The board knows what we have here and the price would be very expensive in either scenario!
A Window of Opportunity to Buy Emisphere. [View instapost]
Thanks for the kind words Bobby! I sincerely believe that we are just getting started and that this could be a $20 stock by the end of summer when we get the final data from the Novartis trials (again I don't see much risk as we are hitting our endpoints and there are no safety concerns).
Palm's Pre Launch Has Made RBC Bullish [View article]
Apps are becoming increasingly more important to success of Smartphones and thus I like to compare the launch of a new Smartphone to the launch of a gaming console. Sega Dreamcast was a great gaming console that was really ahead of its time, but developers were hesitant to jump on-board because they questioned the ability of Sega to sell enough systems to make their investment in developing games pay off. Consumers were hesitant to buy the Dreamcast because they didn't see enough "must own" games. The situation became a circular conundrum with both the developers and the console purchasers waiting for the other to step up. I see Palm Pre being in the same situation, with not many third party developed apps available come launch day.
The other thing that makes me seriously doubt Palm Pre being successful is what consumer really wants more choices in Smartphones? It is not like iPhone and Blackberry users are unsatisfied, in fact quite the opposite as both products users are fanatical with customer satisfaction rates that are off the chart. Oh and one other thing, Apple is coming out with a new iPhone soon and a major upgrade to the OS of existing iPhones that my tech savvy friend said addresses "90% of users requests."
I see the Palm Pre as going down as one of the worst highly anticipated consumer electronic flops in history and that is why we recently shorted the stock. I think that the launch will be so horrible in fact that Palm will have trouble keeping up the appearance of "shortages" for much more than a week. I am certain that the Palm Pre is a great product, but many great products throughout the years have ended up in the boneyard.
Cytori Therapeutics: Soon to Be Sold to Olympus? [View article]
"Gross margins were up 20% sequentially to 72% during 3Q08 thanks to cost-cutting in the form of reduced R&D + G&A expense, offset by higher marketing costs since the 1Q08 launch of the Celution System."
Gross margins are calculated before R&D and G&A and thus would not benefit from reductions in these expenses. This is accounting 101 stuff. No offense, but you should really understand this before posting an article on seekingalpha.
Market Punishes Perfect World for Earthquake; Buying the Dip [View article]
The reason for the stock sell-off is not the Revenue Guidance, it is because the company said margins are going to come under pressure because of increased spending. Increased spending has nothing at all to do with the earthquake. In my opinion it was pretty bad that the company said that they are going to have lower margins with out quantifying how much lower. I think the stock breaks lower again today.
What's Bad For Bisphosphonates Is Good For Emisphere [View article]
What's Bad For Bisphosphonates Is Good For Emisphere [View article]
saveourbones.com/proli.../
What's Bad For Bisphosphonates Is Good For Emisphere [View article]
What's Bad For Bisphosphonates Is Good For Emisphere [View article]
1) They tried to go the risky, abbreviated route with a 505(b)(2) trial, skipping Phase I and Phase II. Because of this they don't have nearly as much data for the FDA and importantly not much safety data (which is also risky because of number 2)
2) I have heard from some scientists that their delivery technology inferior and their are talk that they pick up toxins and other drugs that the patient might be on and put them into the bloodstream. I am far from an expert on this so I don't have an opinion on whether this is true or not, but given that these opinions are out there more safety data would be better.
3) Even if they get approve going the shorter route their endpoint is weak. Novartis/Emisphere's Phase III Primary endpoint was reduction in fractures while Tarsa/Unigene's was increase in bone density. This would lead to a much inferior label for Tarsa/Unigene if approved.
4) Novartis had the exclusive license to use Unigene's Salmon Calcitonin manufacturing technology. They agreed to allow a sub-license to Tarsa. They would not cut their own throats so I am certain that they are making enough of a percent markup, or royalties that would keep Tarsa from dramatically undercutting them on price.
p.s. I probably should have brought this all up so thanks for pointing it out!
Still No Fear of the Emisphere [View instapost]
I have heard that the FDA and the EMA are transitioning from X-rays to MRI's for OA trials, so even though we missed the JSN in Europe and possibly will in the US I don't believe that the claim of positively modifying the structure of the disease is dead. The FDA and the EMA have already shown signs of accepting MRI analysis and that is why it was included as a secondary endpoint. Maybe Novartis/Nordic foresaw X-rays as problematic from the get go? Such an interesting situation, right?
Don't Be Afraid of the Emisphere [View instapost]
The DMC are by no means experts on OA and they do not make judgment calls on the whether or not a drug is approvable. They are statisticians and they tell you whether or not you are trending towards hitting your endpoint(s), nothing more, nothing less. Therefore they would never concern themselves with FDA standards for approval. I hope this is helpful.
Don't Be Afraid of the Emisphere [View instapost]
Emisphere: Set to Shake Up the B12 Market [View article]
A Window of Opportunity to Buy Emisphere. [View instapost]
Palm's Pre Launch Has Made RBC Bullish [View article]
The other thing that makes me seriously doubt Palm Pre being successful is what consumer really wants more choices in Smartphones? It is not like iPhone and Blackberry users are unsatisfied, in fact quite the opposite as both products users are fanatical with customer satisfaction rates that are off the chart. Oh and one other thing, Apple is coming out with a new iPhone soon and a major upgrade to the OS of existing iPhones that my tech savvy friend said addresses "90% of users requests."
I see the Palm Pre as going down as one of the worst highly anticipated consumer electronic flops in history and that is why we recently shorted the stock. I think that the launch will be so horrible in fact that Palm will have trouble keeping up the appearance of "shortages" for much more than a week. I am certain that the Palm Pre is a great product, but many great products throughout the years have ended up in the boneyard.
Smallcaps Flush with Cash [View article]
The Texas 'Wind' Emergency, the Smart Grid and the Dumb Grid [View article]
Cytori Therapeutics: Soon to Be Sold to Olympus? [View article]
Gross margins are calculated before R&D and G&A and thus would not benefit from reductions in these expenses. This is accounting 101 stuff. No offense, but you should really understand this before posting an article on seekingalpha.
Market Punishes Perfect World for Earthquake; Buying the Dip [View article]