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Support seems stronger over the last few days. Problem is where do the 10 million shares of buying come from without a catalyst (news)? that's what I believe it will take to get above $1.25 and hold. We will likely have to wait until the 10Q to get out of this funk....if there is something to glean from it that is positive.
Extremely tight and coiled. Could go either way, depending. Without buying, likely to stay here. No catalyst to go up, I believe everyone is watching to see the break, not jumping in to effect the break.
IMO, NWBO will not be ready to present at SNO. Never the plan, and based on delays and complexity of peer-review and ECA evaluation for endpoints, taking longer than expected. Before the end of the year would be great, but we just don't know. And, unfortunately, we will not get any clarity on timing in 10Q next week.
Agreed, and they didn't say never, just only if the timing coincided with release.
Ok, but I am pretty sure it was discussed at the time that it was a recorded show and likely was recorded just prior to data lock. Either way, they were advised in a different direction for announcement at or around that time and they have stuck with that direction since, without a conference being the focus. Good, bad, or indifferent.
Do you have the dates of his comments on that show? I am pretty certain he said that before data lock and change of plans.
Correct. I am more interested in any restructuring of $11 million loan and how much warrant conversion money has come in to keep the lights on. Those items along with the subsequent events section. Not much more to glean, IMO, based on how they communicate. Will only say what they HAVE to say.
I got the sense, in my conversation, that the Lancet article and references to FDA (and external controls) means they are past that worry. I do not believe they are waiting for anything else on that front.
I did ask about BLA submission but obviously no comment. The connect-the-dots bullet points are compelling, which is why I am still here. It's enough to mitigate my frustration with the time that has passed...probably until year-end, then we'll see.
My takeaway is that there is confidence there. I don't believe there is ambiguous data results. I think all of the steps they are taking is simply to get to the point of presenting the irrefutable. Even so, I believe they think it's still a David vs. Goliath situation, thus the delays to try to get it perfect. Concurrent efforts in steps is another. What may have started as linear is now happening simultaneously. In other words, I think final review by SAB, Experts, peer-review for Journal, are happening at once. They want PR/TLD and Journal will be very close together, as they've said. The sticking point is Journal timing. The "business decision" to go solo with TLD before Journal acceptance or publication date (in line with desired TLD) could be in play but it clearly doesn't sound like the first choice. Would love to see it all play out before year's end, but no gut on that.
So much for a run up to SNO. WTF.
Topline will come with a Journal as close together as possible, they have said that is the plan. Conference, if coincidental to the other two pieces, then probably that too. The only way they present at SNO, IMO, is if they have concluded a Journal article is simply taking too long. That will be a business decision to go with the TLD on its own prior to any Journal confirmation. However, I doubt that will happen.
Based on the the company saying they will only PR milestones and/or then TLD/Journal, they clearly PR'd after they received the assessment and fixes needed. The fact that they felt comfortable to do a PR tells me they think it's easy fixes. JMHO.
I would normally agree. However, in this case with the HTA approval, and the almost concurrent inspection by MHRA, the approval will be faster. There is some cross-over in standards for these certs, I believe.
If we get through a hold above $1.20, Could be a big breakout week next week, IMO.
Never underestimate the power of a leak! Right Gus? DI talked about how many people were involved and seemed proud/surprised that nothing had leaked. That's a tell to me.....
LG's comments were prior to data lock and new "steps" plan I believe. Nothing has changed from the October 5th PR, and DI is adamant in telling people that. And, that stated TLD and Journal, no talk of conference.
....all coiled up and hissin' -REO speedwagon
There will be a presentation. Likely a topline PR, news conference with several esteemed experts (LL, Prins, Bosch, Ashkans, LP, etc.) to discuss and Journal, peer-reviewed, the same day or week. It will be National news and irrefutable.
Disagree. LL deserves a lot, but she also knows the process and players and as frustrated as she may be with it, like you and me, it's the only way to get this to patients. We will have news prior to SNO that will move the price higher, IMO. 10Q will have info that helps and MHRA cert should come prior as well.
Yes. I knew $1.20 would be a short term problem, but didn't expect a retrace back under $1.10. Next push back up should get through. Add the potential news upcoming and the approach to SNO, I think next week we get there. A strong finish this afternoon would help.
There has been zero indication they are planning to so not sure where the disappointment would come from. They have said they are trying to get to topline and journal. With the likely restrictions a Journal would put on any public statements prior to journal article, I would think it's almost impossible. Nothing at SNO would actually tell me we are closer to topline/Journal combo release BECAUSE there is nothing at SNO.
There is no Friday FOMO at this point. Maybe starting next week as we approach SNO. I, personally, do not believe anything will happen at SNO but I believe there will be a run up towards it. And, we could get MHRA next week and we have the 10Q in 10 days....
Still not thrilled about the delays and lack of timeline but it is what it is. I think we are close. Meaning a few months at most.
These processes and the "steps" outlined in the goal of TLD and Journal are working concurrently at this point. Sawston, MHRA, data analysis, article, and maybe even BLA....
We wouldn't be where we are today if endpoints were a concern. "acceptance," if you will, in whatever form the FDA conveys that, was done with the revised SAP and put to bed with data lock. We are in the complicated review process of a new (external controls) evaluation process and it is taking longer, that's all.
agreed. My take on the delay is that once data was locked, a new process was employed. Where in years past, the data tables and endpoints, curves, comparisons were done in a pretty standard fashion, this changed with our trial. Adding external historical comparisons slowed the process. Then, while evaluating, the SAB, Experts, peer-review, etc...were looking at a trial from a different perspective than ever before. There were likely more questions and requests, therefore, the delay. I think we are close now though. Just will be Journal timeframe now.
Not a chance. Everything LP is doing is signaling she is going to try to go it alone. If she was looking to sell, she would have simply waited for topline and let a BP take it across the approval finish line. She may get bidders after topline, but will have more leverage for partnerships or higher buyout price with manufacturing in place.
No. What I can say is that he was clear that several items are out of their hands and they are jumping through hoops to respond asap when asked for additional info. That would be regarding data review and Journal I would imagine. The connect the dots game was discussed again. Paraphrasing, but some of the questions and "dots":
Ask yourself WHY we would be doing things that we are doing?
Sawston build out and certification?
Did you read the Lancet article RE: external control arms? Who was involved in writing that? (Tim Cloughesy/UCLA)
Have you been listening to LL when she has spoken recently?
Is it faster to get RA approval if you have manufacturing in place and certified?
What would we have to do if we knew we had bad results in hand?
So, nothing new really. Not going to PR anything but Material info and milestones until TLD/Journal. HTA was PR'd, MHRA may be PR'd. Still no idea on timing, which is why I believe first quarter, I hope I am wrong.
Lots of cryptic comments from Bigger. He obviously knows something and can't say it.
Like I said earlier, if we didn't get volume this afternoon there would be scalpers taking profits.
No dry powder this week, maybe scratch out 1500 at 1PM.
The afternoon trading will tell the tale if there is confirmation in this reversal. Hold steady this morning. If we get through lunch without a hit, we should see continuation of yesterday's move. If volume doesn't pick up by mid-afternoon, we may see scalpers taking their pennies off the table.
It will be 13 months on Friday. 10Q on the 15th. MHRA cert anytime. Some positive news on financials will help, hopefully: restructuring $11 million loan, warrant conversion money, etc. MHRA approval will also boost PPS a bit, IMO. Still not sold on any SNO reveal. Think Journal is in control.
I spoke with him for about an hour last week. Haven't posted about it as there is no new info that he can give. No time frames either, obviously. The connect the dots conversation came up though and there is definitely a confidence level there. So, I wait.
Yep, felt better about it yesterday, but still ok with it today. I believe we need a serious confirmation tomorrow to make me a believer in the reversal. Like JSmails said.
Sojo, Are you still feeling a pop today? Certainly coiled here....but need some heavier buying.
I believe next info will be 10Q. Hope I'm wrong. Could be MHRA, but we have seen they are proven to be slow.
10%.....I do not think the Journal Article will be accepted and scheduled prior to SNO, and we will be abiding by their disclosure time frame once it is. I believe sometime in December.
Sojo, I think you may be right. Selling has been absorbed well, may see a pop into close.