danny in denver and his ILK are laughably TRANSPARENT
they deceive themselves when they think they are out in front of a bunch of muppet lemmings
the market figured GALENA out some time ago
Sentiment: Strong Sell
Hello Gene: I've read the data presented by others (below) and would not be able to provide more information than what others have posted. Recurrence rates data are not as well documented as one would ideally wish when conducting the sort of study as with NeuVax P-3. Furthermore, recurrence rates vary considerably, depending upon the number of positive nodes, the Standard of Care protocols, the proper pathological analysis presented by the individual patient, etc. The best Galena management could do in approximating NeuVax Phase III Trials 70th recurrence timetable is, at best, only a rough guess based upon the best data currently available. Offsetting this "best guess" scenario becomes even more complex with respect to the European and the Asian populations also participating in this P-3 study. With all of the unknowns and variables taken into consideration, it's been my impression that Galena personnel greatly FAVOR the delayed 70th Study recurrence. Why so? If NeuVax were not performing well during the course of the PRESENT Study, it would be reasonable to expect that by this time of the Study's evolution the 70th recurrence would have already been experienced (given recurrences from among Both the non-NeuVax treated population and within the NeuVax population as well). As we are witness, the delay in registering the 70th recurrence bodes as a major Positive for the time being. Dan
Hi Orchids - The phase 2 trial actually had 187 assessable participants in it. The trial was set up with all HLA-A2/3+ participants (108) going into the vaccine arm and all HLA-A2/3- (79) going into controls. 45 (18 vaccinated and 27 controlled) of these participants were in the subgroup that made up the SN-33 (NP) booster program. Given that, most of the differences between phase II and III are not driven by size differential, as far as I know, but there are some changes.
1) Importantly, HLA-A2/A3+ patients are being used in both arms: (HLA-A2/3- made up the control arm in ph2). This might actually improve the HR because the HLA-A2/3+ participants were found to be more susceptable to recurrence in earlier trials. HLA-A2/3+ patients have less hormonally sensitivity and therefore receive less chemoprevention then the HLA-A2/3- patients and therefore are more apt to recurrence.
2) Second, the ph2 trial had no immunoadjuvant-only arm; therefore, one could question whether the responses seen were because of GM-CSF alone. The control arm in phase 3 will have a group that receives GM-CSF only. Although, it is unlikely that the GM-CSF was responsible for any reduction by itself based on data available from the ph 2 GP2 trial with a GM-CSF–only arm.
3) The Leica companion diagnostic that was used to identify phase 3 trial participants that are HER 1+, 2+ will greatly reduce discordance. I do not believe it is known which patients in phase 2 were categorized incorrectly and whether that had a positive or negative effect on the results.
The benefits of a larger trial are of course that it provides more opportunity to observe adverse effects and the ability to detect smaller differences but still be “statistically significant".
Sentiment: Strong Buy
This is a question I wish I had asked at the shareholders meeting but I believe their timeframe was estimated with an expectation of 60% to 80% recurrence reduction in the vaccine arm.
Sentiment: Strong Buy
As soon as someone posts what #$%$ Avi is ~ it begins using the bogus alias id's to lie. Just click on its name and you will see tens of thousands of lies about hundreds of companies all Short - purebs#$%$ - desperate shorts about to get squeezed.
5 Big Data hits between now and Jan -
Two earnings reports
AnagrelideCR Phase 2 Final Data
FBP Phase 2 Final Data
NeuVax Herceptin P2 Data
NeuVax Phase 3 Interim Results
Lots of activity
10 seconds vs 20 minutes dissolvibg film vs swallow a pill