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And this part:
The ILAP offers “a genuine and significant opportunity to ensure new and innovative products reach patients across the UK, safely and quickly” – Health Improvement Scotland
Steve Bates, chief executive of the UK BioIndustry Association, welcomed the implementation of the ILAP, saying the BIA supported a “joined-up life sciences ecosystem” that would allow the UK to become “a leading location for research and development of innovative medicines to the benefit of patients.”
Yes, that's the article I was trying to find. DI mentioned it on my call with him last week. He asked me if I thought it was important what the MHRA was doing in the UK? He also stated, as the paragraph below suggests, that the (non-EU) UK wants to be a leader in immunotherapy.
“We are transforming the MHRA, making the regulator an enabler of innovation,” declared MHRA chief executive June Raine. The ILAP has “established new partnerships to robustly and safely support all new medicines at any point in their development, and most important of all, involve patients in all aspects of decision-making,” Raine said.
Some placeholders were set by others, not company directly, like LL. It's clear from my conversation early last week and from others who have posted their communications with DI, that they have settled on a path which includes topline followed closely by a Journal article. No idea how long that will take. Like DI said to me....SAB, steering committee, Journal reviewers, these are scientists, not shareholders in most cases. PPS not first concern. Unfortunately the timing is out of our control again. The last Journal took 9 months! Although that was blended, blinded data from a company on everyone's shit list at the time. This data, if stellar, will get buy in much faster. Hopefully we are three months into a 4 month process!
Understood. I believe much of that discussion with large shareholders has likely taken place. If you think about warrants and options outstanding, who would agree to suspend it there weren’t some guarantee you would actually be able to get your shares? Right now, if all converted Warrants or exercised options, it would be musical chairs, and a couple hundred million shares would be left standing. And, if we agree that LP’s plan is to get topline and journal out next, and data is really positive, we can’t do anything next without tens of millions of dollars.
ASM will be early this year, IMO, like end of February. If so, it will be an indication of positive results. Why? LP will need a lot of money to push approvals through. We are technically over our authorized share level. She needs a vote to approve either a reverse split or to increase authorized shares. I don't think either get approved without topline release and peer-reviewed article first.
Still blinded as of Sept 30th. The "subsequent events" sections deal with material info gleaned after Sept 30th but before filing 10Q. That said, they do not have to (and did not) disclose that they are unblinded.
Well, I hope we have topline before April when the 10K annual is due (or the next delay notification of filing).
I am more concerned with material disclosure rules the other way. Meaning, how long can a company hold materially positive news without disclosing? A positive topline would dramatically increase share price. People are making buy/sell decisions today, when material information has likely been in the hands of the company for a couple months.
I agree topline and Journal are tied together, as the company stated. However, an embargo cannot restrict a company from SEC obligations. There will be a complete, comprehensive topline PR prior to Journal, IMO. Then a much more detailed Journal article right behind the PR. Assuming the company was unblinded by mid-November as I believe, and given the number of endpoints, subgroups, etc. from a 14 yr trial, we will be lucky to get a peer-reviewed article before next month. How long did it take for the last one? Nine months I believe. I don't think this will be the same as I am not sure they would be able to hold material information that long without disclosure....
That is true, And I think, understood by all.
3rd Quarter ended 9/30. Data lock PR'd October 5th. They were 100% blinded at the time. Probably were unblinded sometime in November. The subsequent event sections are items that have happened since 9/30 but prior to filing. They do not have to state that they are unblinded, and based on their strategy, would not include that.
I saw that too. Wow, great legal BS.
It reads "Not more likely than not"
Re-written:
It is Not more than 50% chance....
The warrant suspensions to allow for financing if needed and to get to next ASM, which means a vote on increasing authorized shares. OR, to ask for a reverse split to free up shelf space for more money when needed.
Potential scenario:
1. Positive Topline Feb 1st.-gets the ball rolling and PPS moving
2. Journal article Feb 11th -confirms the data and first GBM trial out of 415 to prove statistically significant.
3. ASM Feb 26th- Reverse split authorized, PPS stable and moving up, real money raised. Regulatory approval process begins.
The filing of the 10Q, in my opinion, eliminates the FUD of potentially damaging items some were expecting.
Appears the delay was mostly wrapped around the Flaskworks deal and valuation along with derivative pricing and conversions.
There was also a revision of prior financial statement related to Sawston facility.
German tax issue ongoing and settlement offered by German tax authority, $585K exposure but sounds like they are still negotiating.
Looks like the October 12 financing and warrant conversion put enough cash into the company to get to topline.
Nothing bad in there, IMO. Also, it's another box checked. Now the delinquent 10Q cannot hold up topline, eliminates the risk of pink sheet move. All good. Also shows there has been money going into the company with some conversions.
You will see Flaskworks valuation/payments. Warrant conversions and suspensions. Any new investments/loans into the company that don't require an 8k. Any resolutions to tax or valuation issues. And, we will see the cash on hand through 10/31, which doesn't help much now. We will have to estimate by doing math on any warrant conversions.
When they repositioned the short-lived CFO, LP took the title back and they have an outside accounting firm who does all the numbers and filings. They present them to LP to sign, then they file. That's my understanding. However, I do not believe the 10Q and topline are related in timing, meaning one HAS to come before he other. When 10Q is done, it will be filed. When topline analysis is complete and PR written, it will be announced (as long as they are comfortable with Journal timing).
You can call it what you want. It's not an official SEC quiet period. It's a self-imposed NWBO say nothing period. DI told me Monday that he (they) cannot and will not say anything about the 10Q (out of their hands until complete) or topline (and anything to do with the trial). He also said there are only about 200 investors out of 16,000 who call, email and complain (me included).
Looks like someone else must be getting divorced. Pummeled this morning.
They didn't say months. They said It will take what it takes to do it right, everyone can come to their own conclusion.
Listen, I'm not happy about either. LP is so worried about naysayers she won't release topline until SAB, steering committee, Bosch, Liau, Boynton, all review and analyze. Then, once written, topline won't be released until they have confirmation of Journal article. That's the plan as I understand it. Could be months.
They will not PR a basic topline. They will PR a complete, detailed analysis. They want to leave no room for FUD. That will be followed closely by a peer-reviewed article. That's what I was told. That's why I believe it will take a few more months.
Months away.
I believe our treatment costs will be in line. Not really worried about that, especially if the extension of life is significant (as blinded data may suggest). If novacure can charge $240,000 per year, we should be able to.
Then there is valuation: DI gave an example of NWBO and valuation based on Novacure $17 billion market cap vs. their current sales and equated that to 2200 DCVax treatments per year (or less than 200 per month), which we can accomplish with flaskworks acquisition and technology.
Depends on your perspective. I make investment decisions, especially in small caps, that include my confidence in management and how they operate. Even if you believe in the science, which I do, corporate governance and mistakes can derail a company. Even with great results there is no guarantee on moving it further for approval with regulators. Or, depending on the plan, it could take years. All of which is fine depending on your risk tolerance and investment strategy. I am not worried about the Adam F'steins of the world and believe the science will speak for itself. The company on the other hand is worried about FUDsters and wants every single duck in a row before doing or saying anything. We shall see.
I think we will see a slow and steady drop without news. Longs will hold but other People (traders, newbies) will lose interest and move to other opportunities. We have nothing to give the PPS a spark until 10Q or topline.
I hope that's true but I believe we will need a leak to move the stock. I don't think we see topline for months. Maybe some tidbits in the Q will move it when that comes out. That could be a month, who knows. All the unblinded data must be with steering committee, Liau, Bosch, SAB, Company leadership and potential peer-review individuals. Something has to leak.
I was referring to my situation. I have shares in 4 different accounts and am stuck without dry powder at the moment. Tax season is upon us and I am hoping we get news before April 15th so I don't have to sell for my tax bill before topline.
For what it's worth I had a lengthy conversation with DI yesterday. As you would expect, he cannot say anything about the 10Q or topline. Most of this is out of their hands. The 10Q is outsourced and whatever the hold up is, it is being worked on. If it were a material negative for the company, there would have to be an 8k. Same with topline. Sounds like all reviews and analyses are in process along with the Journal peer review, but no indication of time to get it done. Essentially the process is the process.
I believe we will get information from 10Q that will answer some questions on warrant suspension, conversions, new investments and Sawston/Flaskworks. Hopefully that info will calm my concerns but again, I have no idea when it will be done. Essentially, either wait or sell.
Interesting that short interest has decreased by 3.5 million shares. That would have been in the two week period from Dec 15th to Dec 31st. Tax reasons? Or, because of the quick bump up from 24th to 29th? Or warrant conversion and squaring up positions?
I don't believe longs with warrants who weren't suspended again are selling much, if at all.
I do believe we are still a few months away from topline.
I think we are farther away. I am thinking months.
Same here.
Zero reply here as well. Either they just don't care or we are getting too close to news? I hope it's the latter.
I don't want a fluff topline PR either. With missed deadlines piling up and a lot of question marks being added (warrants, 10Q, Journal), I just want them to give some guidance on time.
We are approaching 100 days since data lock. Are we closer than that to topline or equally as far or is it still a complete unknown that could be ASCO again?
Do we have to produce a 10Q prior to topline?
Can they raise money prior to 10Q? Are they out of money?
These are fair questions for a shareholder to ask, and some answers are required by law.
LOL. Investor relations said buzz off? That's nice. Friday he said he would be happy to discuss my concerns and I replied that I would make myself available when he was. No reply. Followed up again this morning, No reply.
The 50DMA held again this morning. General trend seems slowly upward however I would rather be pushing on the top of the range than testing the bottom. I think you meant 10Q after hours. I hope so.
Doubtful. This is preliminary info on a Phase 2 trial, 57 people. Tryn2 said earlier he had a friend who had to sell due to a divorce. Who knows. I keep saying that the lack of updates is the reason. I'm sure there are those who think there will be news every Monday and trade on it if not.
Doubt it. LP doesn't have as much control there. Although, this may be their honeymoon period. Even at $22.50/share it's still only 350 million market cap.
More than doubled in the past month.
Correct. The only new info in the Oct 5th release was the apparent tie in of topline release to a journal article. Inferred, since there was no clarity on timing or how close together they would like them to be.
To your point, they stated multiple times when topline was supposed to be. Now, No timelines, no pedal to the metal. Since then it has been "we are going to take our time and get this right." Again, fine strategy if it makes sense. But, it is not what they said and I believe they should give us an update.
that's hilarious. While it's true that any investor can and should make their investment decisions accordingly and buy or sell based on those decisions, this is turning out to be much different. The anger from many here, myself included, is that mgmt has stated several times when topline would occur and that they would give updates if the plan changed. So data lock was more than a month late, ok. But to go silent for almost 100 days while not filing the 10Q is unacceptable, IMO.