Could be the "other findings" relate to how the patients are surviving well past the time they should have... and with a quality of life unimagined for such patients. If these are some of the other findings... then perhaps the company has been in discussions with whoever the appropriate parties are on the criteria (besides RECIST) that can be used to measure overall response rate (ORR). T-cell infiltration... CD8/CD4 ratio ... TH1 response... tumor necrosis... all of those "sciency" things they've been looking at in the two previous abstracts... may play a role in these "other findings".
And remember... the House committee unanimously approved the 21st Century Cures Act on May 21 to help speed new drugs to the market. If you want to read more about that... look at the i-hub info section under FDA Endpoints and Approval Information.
Regardless... I know we're all very excited to hear what Dr. Bosch has to share. :)
I did verify... Dr. Bosch will then discuss these "other findings" in connection with the company's plans for the Direct P2 trials. I wonder what these other findings will be?
I'm embarrassed for Zucchini too. Poor guy... I think his brain's in a vegetative state. :)
Thank you f-cancer. Excellent post. I'm looking very forward to Saturday. I wonder what those "other findings" are that will be discussed? :)
As da_woof states below... L has been granted orphan status. Why it's relevant is it means if L is approved, it receives an extended exclusivity period, enhanced patent protection, marketing rights and other incentives.
I humbly accept your congratulations bitcoin. Will you humbly accept your demise should NWBO present impressive data in this Industry Expert Theater you call a garage?
I'm actually more excited about hearing how Direct is working than having the share price rise. Although validation is always sweet. I do want to know too... how many people in the trial can still raise their hands because of Direct. :) And I hope we find out which cancers Direct goes after for P2. I wish they had enough money to go after all of them. Maybe Woodford could put in another 100 million?
Thanks Itrizia... I'm always interested in possible short theories.
No... I was just using artistic license... saying he was facing a wall and not able to turn around. So whatever one sees when one faces a wallI is what I meant... maybe I should have said "plaster" instead of stucco. :)
He's not vanished... you just aren't familiar enough to recognize him. I think Pyrr walked himself into a corner... and his pride won't let him turn around. So he faces the wall and looks for red flags in the stucco. Too bad... his loss. Your loss though... will not receive any sympathy from me.
Yes to disease progression counting as an event.
That's why the primary endpoint is PFS or "Progression Free Survival" and not overall survival (OS). When the patient on the placebo side "events" - hopefully not death but just progression - they are allowed to cross over - but their event is counted towards the total 248 events needed (149 needed for first interim analysis).
An event is an event (death). Yes, death is an event. But so is progression... something at over 25% tumor growth or new lesion at 1 cm or larger.
You are right mouse... if you have borrowed money from your broker, the broker can then access a value from your account that equals a percentage of what you've borrowed. At Charles Schwab, I think the amount was 150% of whatever you'd borrowed. Now that doesn't mean they are using your NWBO shares... they could be using any shares that you are invested in... up to that amount. I think this request should be to those who can call back their loaned out shares.
Right... but they could never have presented up to date survival data from Direct at ASCO with an abstract that was due by Feb 3. And while we know that we will hear something "new" now (as Les' email that accompanies the PR states that specifically)... we don't know much"new" they can give us at this time. I'm sure it depends on whether the outside data analyses is completed.
If it's not, they probably intend to give us something meaty... but it may not be all of it. Presenting in this manner also allows them to give what will hopefully be impressive data at ASCO (even if it's not sponsored by ASCO - it's there), protect the data from the press (who would have had earlier access to it), and finally, allow them... if they intend to... give us more aged data... versus data obtained, written into an abstract, and submitted no later than Feb 3.
I agree... it's a very risky proposition for those shorting it. This Saturday is not a good sign at all for shorts.
So much depends on the extent of the subject matter. Will it be a fuller presentation on Direct? Will we hear about the 2 P2 trials? Is there a partnership mixed in there somewhere? And update on L? Germany? Something from the UK? What did the timing of this event marry up to on the list?
Good point. When the control arm events... the event is counted towards the primary endpoint of PFS. But they do cross over and then receive L... which would mean they too would most likely be living longer than patients historically do. So even control OS figures most likely will not look like historic OS. Interesting point... and not a bad problem to be faced with. :)
jehoshaphat... because they are not presenting on an abstract that was submitted to ASCO, the rules prohibit them from stating any affiliation to ASCO.
"No marketing materials or communications of any kind, advertising, or other written or spoken descriptions of the Theater presentation may use the ASCO or Conquer Cancer Foundation name or logo, or otherwise suggest or imply that ASCO or CCF has endorsed or sponsored the presentation. The name of the ASCO meeting may be mentioned one time in each communication for identification purposes, in a reasonably-sized, neutral font. ASCO, the Conquer Cancer Foundation, or the name of the ASCO meeting may not be part of a title or heading of the Theater presentation, be prominently featured, or listed first in print materials. ASCO slide templates, color schemes, or other means of confusing the Theater presentation with an ASCO-sponsored event may not be used."
Go to the ASCO meeting site... click on Resources... drop down menu shows "Exhibitors"... then look for "Policies" - kinda in the middle, right side. Click that and you'll see the link to "Industry Expert Theater Guidelines".
They had to word this PR in that manner. It doesn't mean they don't intend to tell us anything new. And I'm also not saying they will give us any new milestones or catalysts. But it merits considerable consideration that they didn't pay $45k to tell us again what we as shareholders already know. It appears they booked this time slot to tell us something new. But they booked it on March 11. That said... if the timing of whatever they want to present is off, there'd be nothing new. The fact that they are providing us a webcast of this event... and they didn't provide a webcast to the same thing at AACR hopefully points us towards at least one white rabbit.