There are six patients listed as having CV deaths. The narratives supersede the data presented in Table 9. I'm not saying that the FDA won't approve Movantik, but this isn't mother's milk either, like some posters seem to believe.
1. Study 04 Patient E4068050 was a 73-year-old male in the naloxegol 12.5 mg group.
2. Study 07 Patient E4073006 was a 54-year-old male in the naloxegol 12.5 mg group.
3. Study 08 Patient E5228010 was a 30-year-old female in the Usual Care group. She was a rollover patient who had been taking naloxegol 12.5 mg before entering Study 08.
4. Study 08 Patient E8843004 was a 39-year-old female in the naloxegol 25 mg group.
5. Patient E4010003 (naloxegol 25 mg)... This death is not captured in the clinical database and is therefore not included in either Study 04 or pooled data presentations. (*This case is not included in the Table above.)
6. There was 1 death in the Phase I studies of naloxegol. In Study 09, Subject E0001005...
For a quick overview, read the June 14 press release "bluebird bio Reports Rapid Transfusion Independence in Beta-Thalassemia Major Patients Treated with its LentiGlobin Product". If you are familiar with b-thal major, those results will knock your socks off. Any presentation you find will have additional details.
It's a quantum leap forward in the treatment of late stage cervical cancer. If NKTR-102 turns in those kind of numbers in the MBC study, the NKTR market cap will increase by billions too. We'd call those results blowout!
Read the ADCOM briefing material before you post again, please!
It's all on the FDA website. Go to the document "FDA Briefing Information for the June 11-12, 2014 Meeting of the Anesthetic and Analgesic Drug Products Advisory Committee (PDF - 16.9MB)". Pages 34-35 have a section entitled "Narratives of MACE in the naloxegol clinical program/Narratives of patients with CV death". Each of the patient deaths during NKTR-118 development is described in detail, including contributing factors.
RTRX director Jeffrey Paley sells 20,000 shares. Cashing in while he still can, I suppose.
There were six CV deaths among NKTR-118 study participants. All had taken Movantik at some point. There were no CV deaths among placebo/usual care only participants. Five of the six were high CV risk patients. There appears to be a trend that Movantik adds to the risk of death in susceptible patients. Although the Adcom panel didn't find an overt signal, they didn't ring the all-clear bell either. Thus, a post marketing study. There is a chance that Movantik could end up with a black box warning against use in high risk CV patients, pending further study.
Here's what I think I heard. Please correct me if I got it wrong.
The reason patients need hospitalization during the transplant procedures is that they have to be preconditioned. That is, after extracting marrow cells to be treated, the remaining bad cells need to be eliminated as completely as possible before the treated cells are reinserted. If the preconditioning isn't necessary, the treatment could be done as an outpatient procedure. This would make it much more feasible in second and third world countries. Sickle cell treatment requires a much lower percentage of good hemoglobin than b-thal to be successful. Although much further research is necessary, treating sickle cell as outpatient is a possibility.
-- "20, 30 or ever 50 day effectiveness"
181 doesn't hang out in the body like some of the other pegged drugs. And it definitely shouldn't, otherwise there would be toxic buildup over time.
I owned NKTR for several years for the potential of 181 and the other pain meds, then sold when the Phase 2 failed. There may be a lot more about 181 that we don't know. 181 Phase 3 is getting pushed back. The 181 Phase 2 and 192 Phase 1 failures got Medve fired. Make no mistake, 192 was a blunder of the highest order. It failed early in Phase 1 due to elevated liver enzymes, and it's hard to believe that this problem wasn't seen in the preclinicals. Yet HR made the commitment to move forward with 192 as the company's highest priority. Are there potential problems with 181 that haven't been revealed? To be successful in the market, 181 has to be better at pain relief than the cox-2 inhibitors. If not it's a niche product only.
DNDN is turning the corner and heading for a cliff. Bankruptcy or massive dilution is in their future. This is from yesterday's 10-Q.
"we are currently considering alternatives to the repayment of the 2016 Notes in cash, including alternatives that could result in leaving our current stockholders with little or no financial ownership of Dendreon."
HR got better terms from AZN for NKTR-118 as an investigational drug than Al Mann got out of SNY for an approved drug.
I'm convinced that mm intentionally posts idiocy to this board just to get a rise out of everyone. His day job is probably a free lance comedy writer.
My God! Here's what really happened.
NWBO came up with the new entry condition... high white cell count. That retroactively eliminated 55 patients who were already enrolled in the Phase III study. Those 55 patients are now considered compassionate use "information arm". But most importantly -- Their results were UNBLINDED. Guess what? There appears to be a slight increase in OS in the DCVax-L arm, but nowhere near the statistical significance needed for approval. This isn't good news at all.
Even AF is starting to disassociate himself from Shkreli. Search for "Retrophin CEO Under Fire for Twitter Faux Pas". RTRX earnings due this week.