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I am a family physician that finally had a Amarin rep come by the office. The main pitch was that the cost to the patient should 9 dollars with insurance. This is the first call I have had since the launch of Vascepa.
Amarin is not going to present at the JP Morgan conference next week. I assume that means they have not yet heard from the FDA.
The JP Morgan Global Healthcare conference starts Monday. Amarin is to present unless it has not gotten word from the FDA. Is there any significance that they have not cancelled this?
There are 26.5 million shares short according to Sheff on I hub. This could get very interesting with a positive Adcom result.
Diabetics also take SQ injections like Bydureon which is a weekly shot for diabetes.
Absolutely. Coupons do not work for Medicare only commercial pay.
As a primary care doc, I have not seen a drug rep. I tried writing a script and the 50 dollar co pay prevented it being filled. I follow the science and I think EPA makes sense.
According to the FDA website the meeting starts at 8 AM and wraps up at 5 PM
I am dissapointed to tell you no one has been by the office to leave samples or detail the product. Appearently I am not on their target list at this time. I see a large amount of acute muscloskelatal injuries and write a lot of generic naproxen. So the fact they have not been by tells me they have not got their marketing act together. I actually sold some shares due to this.
Vimovo should be available in the pharmacy around the first of August. Official launch sounds like it will be in Sept. I am interested to see how it is priced.
My AZ pharmaceutical rep said today they would begin detaining the new drug Vimovo the end of August. She is unable to discuss the drug until then.
Nortriptyline is an older drug with more side effects and risks. It does have a stronger norepinephrine efffect so it does help with pain issues. The dry mouth, potential cardiac arrythmias and risk from overdose are the big problems.
The Forest rep was just in the office. They are claiming 1/3 of patients taking Savella get signifigant improvement and another 50% get some improvement.
My experience is that it is better than Lyrica or Cymbalta however fibromyalgia is pretty subjective and the disease is difficult to treat.
Market cap this morning was 14.9 mil with 68 million shares. We now will have 10 mil in the bank and the potential for more money down the road plus the high impacts and perhaps ADD. I'm not sure what the current valuation should be but a double from here does not seem out of the question in the short term.
Trading
Why is the volume so low this AM after the news. I placed an order that has not filled at this time. Does this have to do with the otc status?
I just heard a story of a 30 yr old patient with sleep apnea who died post op after a routine cholecytectomy. He was receiving IV morphine and appearently was on CPAP. I asked if the doc would use a drug that prevented apnea and did not decrease the pain relief of morphine. The answer was an obvious yes if such a drug existed.
Here is another approach to inoperable pancreatic cancer. The numbers sound impressive however this seems like a last ditch approach.
BSD Medical Reports Initiation of a Phase III Study on Pancreatic Cancer Using the BSD-2000 Hyperthermia System in Combinatio...
BSD Medical Corporation (NASDAQ:BSDM) reports initiation of a randomized, multicenter Phase III clinical study using the BSD-2000 Hyperthermia System in combination with chemotherapy for the treatment of pancreatic cancer patients after R0/R1 surgical resection of their tumor (complete removal or only microscopic tumor remaining). The coordinating investigator is Rolf D. Issels, MD PhD, Department of Medical Oncology, Klinikum Grosshadern, Munich University Medical School, Munich, Germany. The Phase III study, which is being sponsored by the European Society for Hyperthermic Oncology (ESHO), will compare hyperthermia with chemotherapy (gemcitabine) to chemotherapy (gemcitabine) alone.
The Phase III study was initiated following completion of a Phase II study that utilized chemotherapy and hyperthermia to treat 21 inoperable pancreatic patients who were resistant to or had failed previous chemotherapy gemcitabine treatments, a patient population with a dire prognosis. There was one complete response (complete disappearance of the tumor), 3 partial responses (more than 50% tumor reduction), and 7 patients with stable disease (no tumor growth). The study results demonstrated a low toxicity rate and an overall survival of 16.9 months. By comparison, the median survival for inoperable pancreatic cancer patients after gemcitabine treatment is only 6 months. The Phase III study, which is being sponsored by the European Society for Hyperthermic Oncology (ESHO), will compare hyperthermia with chemotherapy (gemcitabine) to chemotherapy (gemcitabine) alone.
Pancreatic cancer is one of the deadliest and hardest to treat cancers and is the fourth leading cause of cancer-related death. There were an estimated 42,470 Americans and 60,000 Europeans diagnosed with pancreatic cancer during 2009 and approximately 80% are inoperable. The median survival period from the time of diagnosis until death is 3.5 to 6 months, depending on treatment, and less than 5 percent survive to five years. Advanced pancreatic cancer patients currently have few treatment options.
The study is scheduled to open for patient enrollment in March 2010. The following clinical sites will participate in the clinical study: Klinikum Grosshadern of Ludwigs-Maximilans-Universität München, HELIOS Schlossbergklinik Oberstaufen, Rotkreuzkrankenhaus München, Universitätsklinikum Düsseldorf, Klinikum Mannheim of Heidelberg University Medical School, Universitätsklinikum Erlangen, Universitätsklinikum Freiburg, Universitätsklinikum Tübingen, and Charité University Medical School Berlin (all Germany); Kantonsspital Aarau AG (Switzerland); and Ospedale Borgo Trento Verona (Italy).
About the European Society for Hyperthermic Oncology ESHO was organized to promote research relating to the use of hyperthermia in cancer therapy and to facilitate the exchange of information among multiple disciplines regarding the study of heat in the treatment of cancer.
About BSD Medical Corporation BSD Medical Corporation is a leading developer of systems used to deliver precision-focused microwave/RF energy to diseased sites in the body, including cancer. Its treatments are used to kill cancer directly and increase the effectiveness of companion radiation treatments for certain tumors. The BSD-2000 is restricted to investigational use in the United States. For further information, visit BSD Medical's website at www.BSDMedical.com.
Could there also be a problem getting a PIPE done?
Looking over the top company on the list HTWR went from a low of .25 to a high over 35$ this year. Why can't we get just a small bump in price. .15 to 2$ would be nice.
It appears Merck plans on staying active in the neuroscience area. The following is a quote from the Motley fool.
" Merck (NYSE: MRK) CEO Richard Clark says his company is looking to do more deals than ever, perhaps "even try to double" the current rate of 50 per year."
A deal with cor certainly would not break the bank.
The news release on Aug 21st stated that there would be a hearing within 45 days. That carries us into October. Lets hope we have sleep apnea data or other news that will make this a non issue.
The little bit of news officially terminating Cobra manufacturing should mean GNVC does not plan to go it alone in manufacturing it's products. I think this bodes well for a pending partnership.
Dew,
I do not share your pessimism. The poster presentation seems impressive to me. The following is from the press release.
The analysis concluded that TNFerade appeared to be safe and well-tolerated. The analysis also indicated a 25% reduction in the risk of death in the TNFerade plus standard-of-care (SOC) arm compared to the patients receiving SOC alone (Hazard Ratio = 0.75; 95% Confidence Interval [0.494 - 1.15]).
Dr. Mark Thornton, GenVec's Senior Vice President of Product Development commented on the poster, noting, "In the SOC patients, 75% of the patients died within approximately 11.8 months. However, in the TNFerade plus SOC group, 75% of the patients did not die until approximately 19.4 months. Although the data still need time and events to reach maturity, we are encouraged by the survival trend being observed at this point in the trial."
Please enlighten me as to why the Hazard Ratio if .75 is bad.
Thanks
It appears they are excluding comorbid conditions such as hypertension. This design will make finding test subjects much more difficult as this is who has sleep apnea.
Only 10 patients have made it through 1 sleep lab study. Slippage now till the end if summer.
IDMI got their delisting notice and then sold the company to Takeda. We did not get as much as things were worth but it happened without any response from the company to the delisting notice.
If they indeed have a signed deal it does not make sense that IDM hired a firm to work to find a buyer for the company.
I am confused. We got European approval today and the stock drops? Mexitech if you are still around I would like to hear your take. Has the world changed so much that positive news does not move this stock.
Here is what another small biotech is doing to keep afloat. I suspect they have not been able to find funding and have elected not to do a PIPE in this enviroment.
GAITHERSBURG, Md.--(BUSINESS WIRE)--GenVec, Inc. (Nasdaq:GNVC - News) announced today that it is lowering its operating costs in order to increase the Company’s efficiency, including eliminating 22 positions. These changes, effective immediately, reduce the Company’s workforce to 101 positions, and have been made to lower the Company’s expenses during this period of unfavorable economic conditions. The Company expects that lowering costs, in addition to revenues from funded collaborations, will provide the company with approximately 18 to 24 months of operating capital
I assume that any such decision would be announced after a EMEA meeting. The next is not scheduled till Feb.
There is still nothing on the EMEA website and it appears their meeting has completed for Jan. Unless there is more posted tomorrow it would seem we are now waiting for the Feb meeting.
I would agree that opioid respiratory depression is totally different from reversing muscle paralysis with Suggammadex. I can see where both would be used to reverse the effects of anesthesia.
Byetta activates the GLP-1 receptor and causes the beta cell in the pancreas to secrete insulin in response to elevated glucose. It also decreases glucagon secretion when glucose is elevated.
There is not a known etiology for pancreatis due to Byetta and I suspect there is little cause and effect with this drug. Diabetics often suffer from gallbladder disease and gallstones are the cause of a signifigant amount of pancreatitis when the common duct gets blocked.
I am suprised that Cortex has anything to do with R&R. I hope this does not mean they will use them for another PIPE.
The CEO has taken on a new company but still remains as CEO. IDMI is awaiting a decision in Sept from the Europeans concerning treatment of sarcoma in children with L-MTP-PE. It is widely thought on the yahoo board that a buyout is expected following a positive decision.
This drug was turned down for this indication by the FDA due to a sloppy application but has been allowed to be used for compasionate use.
What measures are used to decide on preservation of analgesia? Is this subjective? I don't see how procedural problems with the mask apparatus would affect pain.
I agree with Davey. I am looking for good news and a pop to 3 tomorrow. Consider the volume when it was announced that Stoll was presenting. I think people are watching but not pulling the trigger until the news is presented tomorrow.
This was posted on Dew's Biotech board today. Based on this information I think the price has to rise signifigantly before we can expect a buyout in the 3-5 range. So to me that says we need approval from the europeans first.
Recent Biotech Buyouts at a Large Premium
[Added APPX.]
Acquired Premium Deal iHub Company Buyer to Market Value Date Reference KOSN BMY 233% $190M 5/08 #msg-29647147 COLY PFE 167% $165M 11/07 #msg-24600805 IOMI Intercell 147% $190M 5/08 #msg-29232165 BTRX Stiefel 136% $150M 6/08 #msg-30201906 ENCY PFE 118% $350M 2/08 #msg-26978155 TRCA Ipsen 104% $660M 6/08 #msg-29795183 SIRT GSK 85% $620M 4/08 #msg-28705020 Jerini Shire *71% $520M 7/08 #msg-30452872 MLNM Takeda 53% $8.8B 4/08 #msg-28365383 APPX Fresenius †29% $940M 7/08 #msg-30498388
You do not think approval will have any effect on the sale price? If a deal has been made wouldn't that have to announced immediately?
After looking further I see the collaberation with Sanofi was dropped in Jan. resulting in the restructing of IDMI I also find where Sanofi owned 7.9% of IDMI as of Sept 2007. I am unsure of Sanofi's role in the company at this time and to what extent they still own any stock.