AZN did an excellent presentation. They continued emphasizing that there were no CV issues. They proposed that they will do a 5 year "observational study" to make sure there are not significant issues. They indicated that were able to mitigate all deaths that occured (one in car accident, one real real sick patient before taking naloxegol, etc).
I believe one of the panel members indicated that he did not consider CV as being a major issue but had question about opioid withdrawal. There were also questions about high blood pressure during the first hour of taking the drug I believe, as well as after bowel movements which if I heard it correctly could not be confirmed as attributable to the drug because it took about 6 hours for the patient to come to the clinic and by then there seemed to be no blood pressure issue.
All of the above is based on what I was able to hear and based on my memory because the discussion was very fast moving and I was not able to take notes. The sound was attrocious and many words nor decipherable.
"02:31 PM EDT, 06/09/2014 (MT Newswires) -- Shares of Progenics (PGNX), Nektar Pharmaceuticals (NKTR), Sucampo Pharmaceuticals (SCMP) and Synergy Pharmaceuticals (SGYP) are all trading higher on Monday after the announcement by the U.S FDA that drugs treating opioid-induced constipation may not require large studies to rule out heart risks before getting approved as the length of these studies might be considered "impractical" in light of the use of the drugs."
Probably Pharmasset. As far as Chinese stocks, I was into XING and QXM and lost my shares on them when the major chinese holder purposely got the stocks delisted and is now plundering the assets and the SEC says it can not do anything about it because the chinese government is protecting these thieves, yet the SEC has continued allowing chinese companies to list their stocks in the US.
I agree with you about all the #$%$ and especially incompetent analysts. And I do prefer to call them " Dung beetle rolling #$%$" than girls. Have a good day.
I like your enthusiasm. However, please stop insulting women with your comments. These sorts of expressions are a no no and only are done by uneducated bigoted people which I know you are not.
"there is a detailed written report from AZN where they answer the issues raised by the FDA----"
I was trying to get that at AZN website and was not successful. Can you give me some pointers on how to access it. Thanks.
"Merck will spend $24.50 per share in cash for each share, which closed at $7.23 Friday. Shares of Idenix Pharmaceuticals Inc. soared almost 240 percent in premarket trading Monday. The boards of both companies have approved the deal. "
I used to own that sucker a few years back but got fed up with it after its initial HCP drug bombed.
3. VOTE: Should FDA require cardiovascular outcomes trials for peripherally active mu opioid receptor antagonists being developed for the treatment of opioid-induced constipation in patients with chronic, non-cancer pain? Discuss your answer.
a. Yes, for all peripherally active mu opioid receptor antagonists
b. Yes, but only for specific peripherally active mu opioid antagonists.
Discuss your answer. If you choose option “b”, please specify which specific mu opioid antagonists should be required to conduct a cardiovascular outcome trial and what concerns form the basis for such a requirement.
4. DISCUSSION: If a cardiovascular outcomes trial is required for a peripherally active mu opioid receptor antagonist being developed for the treatment of opioid-induced constipation in patients with chronic, non-cancer pain, discuss whether the trial should be required in the pre-approval setting, required in the post-marketing setting, or in a combination of pre-approval and post-marketing settings.
5. DISCUSSION: If a cardiovascular outcomes trial is not required, discuss whether a longer term controlled clinical trial should be required pre-approval to further assess the safety of peripherally active mu opioid receptor antagonists being developed for the chronic treatment of opioid-induced constipation in patients with non-cancer pain. Describe specific outcomes that should be assessed in such a trial and the appropriate duration of the trial.
FOOD AND DRUG ADMINISTRATION (FDA)
Center for Drug Evaluation and Research (CDER)
Meeting of the Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC)
June 11-12, 2014
1. DISCUSSION: Discuss whether the totality of data suggests a cardiovascular safety signal associated with the use of peripherally active mu opioid receptor antagonists. Include in your discussion:
a. the strength of the signal
b. whether you believe the signal is limited to a certain drug(s) within the class or whether you believe there is a class effect
c. the biologic plausibility of the signal:
i. the effect of opioid withdrawal on the autonomic nervous system and the relevance of hemodynamic changes on risk of cardiovascular events
ii. the effect of off-target receptor affinity for opioid receptors on the heart
iii. other effect(s)
2. DISCUSSION: Discuss the feasibility of conducting a cardiovascular outcomes trial in patients with chronic non-cancer pain who have opioid-induced constipation, in which patients are randomized to the peripherally active mu opioid receptor antagonist or placebo, as add-on to background therapy. As part of this discussion, consider what would be an acceptable degree of risk that would need to be excluded in such a trial.
As far as I am concerned at this time I am more worried about the FDA panel not recommending 118 or require a longer trial before approval than any concern that I may have about how much revenue it will bring.
Does any one know if Adam Feuerstein is attending the FDA advisory meeting and blogging the proceeds?
Cystic Fibrosis - Quest For Kalydeco
Some GREAT inside info from someone who likes our page for those Cystic Fbrosis double F508del people.............."My daughter carries the two copies of delta 508 just before Christmas of 2012 she was really bad she had an infection that was not responding to antibiotics she came home for Christmas and then in January she had a turn for the worst her body couldnt fight the infection she stayed in hospital for 8 weeks she had numerous pneumothoraxs ended up on a ventilator and it was touch and go for a few days but she pulled through it then when she got a bit better came the conversation that we all dread from the consultants its time to start discussing lung transplants my daughter said "im not ready for this" and started to fight again as all cfs do she managed to get het lung function to 38% then a few months after we came of holiday we saw a new trial that was going to be taken place the trial for kalydeco and lumocaftor she had to blow 40% to get on the trial which she did but it was a double blinded study for 6 months. After the 6 months which ended in march she was given the active drug ....so to cut a long story short we went to clinic today sats was 97% weight up to 55 kilos and lung function was a whopping 59% so please whoever decides who gets these drugs please look at the facts of how lives are changing look at the faces of the families the relief it brings to the cfs knowing that they can breathe better and then tell us that its not being funded due to costs. My daughter has not been in hospital for 12 months and has not had any ivs in 12 months she is enjoying life and thats what lifes all about. It really is like looking at a different person!" .... What a fantastic message. Thank you!!)
"What are you, nuts?'
I don't mind being nuts if we get more than $20. I guess it is possible that $20 would be too low if the stock appreciates greatly in case of 118 's approval. It is just that lately, I have become skeptical that in the immediate future any good news is going to move PPS. For some reason there is no respect for NKTR pipeline and even with the recent good news the stock tanked instead of going up. May be it is the shorts that won't allow PPS to go up by relentlessly shorting the stock? Maybe it is because investors are not interested in HR being at the helm ?
Hey, I don't mind being wrong in my assessment.
In case 118 is approved without any strings attached, IMHO it won't surprise me if AZN makes an offer to buy NKTR. Since they have to pay a royalty for a long time, they may figure that even if they offer $20 per share, not having to pay that royalty makes such a deal a steal.
"Wal-Mart CEO says company may target a 3-D printing acquisition, DJ reports
Wal-Mart (WMT) CEO Doug McMillon said the company's pace of acquisitions is going to accelerate and that the company's target could include 3-D printing companies, according to Dow Jones. Publicly traded 3D printer makers include 3D Systems (DDD), Stratasys (SSYS), ExOne (XONE), and Voxljet (VJET)."
I hope Wal-Mart buys DDD and put this inept management to pastures.