I'm pretty sure they'd have to push through an additional trial for that, although I think it's likely that they will at least pursue it.
My guess would be no, and I'll explain my reasoning, but remember that I am not a doctor, or an expert in the field.
The issue, as I see it, is that a cell in a non-cancerous tumor does not have immune markers that are different than a normal body cell. Therefore, there is no way for the dendritic cells to identify it as tissue that needs to be destroyed.
And I copied it from the other PR on NWBO's website. The statement by the Minister is not consistent with either NWBOs PR or with the actual description on the UK Government's EAMS page.
No it doesn't say "proven in trials". It says "based on available clinical data", meaning they can use the P1 study, and the expanded access data that are already public, and they don't have to wait for the P3.
AF hit piece later this afternoon, or tomorrow morning?
And also post your guesses about the spin. I'm going to go with "going this route because they don't think they can get FDA approval".
In return for which, the partner gets partial ownership of NWBO (or at least it's treatments). No, no actual shares are sold, but the ownership is still diluted.
How is a partnership any different than dilution? Either way, the eventual gains are split.
Yes, but official documents are issued in German. And legal translation isn't something you can just plug into Google translate (as evidenced by the fact that AF's headline had "Uberseitzung" in it, which is not a word without the umlaut), and get results. A week or so of going back and forth to make sure the exact meaning comes through is not unusual.
From the press release 11 Aug 2014:
"Taking into account the time required for these approvals and implementation steps, and the 36-patient increase in the trial, as well as the gradual ramp-up of the trial in Europe, the Company currently anticipates that enrollment will be completed in approximately Q3 of next year, and the primary endpoint of the trial will be reached about 3-5 months after full enrollment or by around year-end next year."
DCVax-Direct Phase 1 Primary Endpoint (Safety) should be reached roughly Q1 next year, although that one I won't swear to. Phase II results, the Clinicaltrials information says June of next year, although a few months delay on that wouldn't surprise me.
By which time, the PI direct trial will be complete. The PII trial of direct will be complete unless something goes very wrong. The PIII should be complete barring significant additional complications.
If the company isn't in a position to raise 17.5m without blinking at that point, we'll all already have lost, so it won't be an issue.
The first treatment was in Q3 of 2013, per the press release of May 27th. Therefore by the time of the June press release, one or more patients had completed the trial. However, the early patients were treated slowly, with 2-3 weeks between patients (same press release), a restriction that wasn't loosened until March. Therefore, while several patients had completed the trial by June, it wasn't until then that a significant number of patients had received the 4th injection, which is when they chose to comment. They never said in that press release that no one was further along than 4 injections, they just discussed the state of patients after 4 injections.
I I am one of a dozen people who has bought 4 books at a particular store in the last month, there is nothing to say I haven't bought 5, or 6, or 50, just that only a dozen have bought 4 or more. You are reading something into the press release that isn't there.
To quote from the May 27th Press release,
" To date, 19 patients have completed at least half of the 6 treatments with DCVax-Direct, which are spread over 8 months. None have yet completed all 6 treatments."
"As is often the case with first-in-man studies, the Company’s DCVax-Direct trial was required, as a regulatory matter, to proceed slowly until safety considerations could be assessed. The Company was required to treat just one patient with at least 2 of the 6 treatments in the overall regimen, then wait 2-3 weeks before treating the next single patient in the same way, and so on, treating just one patient at a time."
"The DCVax-Direct trial began treating its first patients in Q3 of last year."
If they started treating the last day of Q3 last year, 32 weeks is may of this year.
This means that some patients had have completed the trial by the time of the press release you are referencing. You seem to think that a patient who has had 4 injections can't have had 5 or 6, and that just isn't true. They were reporting on the state after 4 injections because that is the one they had significant data on, not because that was as far as anyone had gotten.
No. There were 9 patients who had received the 4th injection BY June 2014, not in June 2014. That 4th injection could have happened 4 months earlier for one or more of them.
I'm not saying this is true or not, we'll see on the 5th, but your poor understanding of the English language doesn't inherently make it false.
That would be last Thursday. Or the week of July 28th if you want a more extreme example. Small biotechs are volatile, and not tied all that strongly to the larger market.
Dunno, why is it up 9.5% in the last month? It's almost like you're cherry picking your start point?
Bumping your own post is bad form. It shows that you're the only one who thinks you actually have something relevant to say.
Considering he is simply regurgitating AFs arguments, and considering that there are at least two false statements of fact in his article (that NWBO is hiding data when the DMC has confirmed they aren't, and the Buzdar is receiving money from NWBO), I would say no.