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No, that's not the way I do it. My first investment in NW was 2008. I'm more like a venture investor. I'm not trying to scalp a few cents. I play the long game.
It's mostly about the money but I'll also feel gratification if they receive commercial approval.
"There is no one alive who is Youer than You."
- TG
What? I thought some accused me of pumping. Isn't that when the stock is supposed to go up?
Ah, yes, I did make a prepayment and then figured out the terms later, when I had time. I've been busy with other portfolio companies.
The basis is conversations with management and with an outside person that has knowledge of the process. I don't think NW can precisely forecast the date and no one told me gave me a date.
The outstanding application to-do items that I had on my list are done. I have no other to-do items on my list, but my best guess is the application is not yet submitted. So, as far as I can tell, just the final review remains. That's how I get to September.
I do have some understanding, but I hesitate to say at this point. I don't think it will change anyone's actions.
learningcurve2020, we've always been respectful of each other, and I've thought that was sorta good. What happened? Can I get you something that will make you feel better?
about $2.7, I think.
Sorry for the v. late response, I haven't logged onto this site for many weeks. Since your question involved OTLK, I'll respond over there.
Apologies to all. I got the timing of the MHRA application wrong. I thought I had a handle on the remaining deliverables necessary to complete the application and made reasonable estimates of time to complete those (with some added time since this is Northwest we’re dealing with). First, I thought it would be submitted by May, then June/July. Well, it’s August and I don’t think it’s submitted yet.
With Northwest, it’s easier to predict if something will happen than when it will. So, I got the timing on this one wrong. Sorry.
That said, I don’t think it changes much. The application will be made and then, the NW investment all turns on UK approval.
If anyone cares, my current estimate for the application is September. Also, in the last couple of months I have sent the company a few million dollars more.
Just my assessment of the timing and order of the company hitting milestones. So, yes, it reflects my prediction of news.
Someone else in my office looked at the ASCO presentation but I haven't yet. That said, all that really matters for now is the UK application. I don't believe it's been submitted yet, but I read nothing significant into that. I think's its close. If Yoda gets a strong feeling about it, I'll pass it along.
First, I don't want to make too big a deal of my original comment. I am the last guy to point to "the shorts" or "market manipulators" to explain price movement. Fundamentals matter way more and usually that all I care about. However, w.r.t Broker Dealers, the banking and prop desks are independent and can hold different views. I also was pointing out that hedge funds take positions partially based on relationships with bankers and the read they get from bankers. There is no material non-public info involved, just relationships and an understanding of where a company's vulnerability lies. Last, my point on 5/22 comment was that short covering may add to the power of the move and therefore we may get a pretty nice rally.
I pulled some short data and see that 500k shares were covered on 5/23. But the short interest remains very high and so this rally should have legs until the company steps in starts hitting the market with their ATM.
Market Date Short Interest Days to Cover Shares Outstanding Short Interest Float
6/2/2023 16,371,148 14.71 256.67 6.38 124.55 108.17 13.14
6/1/2023 16,371,148 17.01 256.67 6.38 124.55 108.17 13.14
5/31/2023 16,371,148 17.45 256.67 6.38 124.55 108.17 13.14
5/30/2023 16,371,148 18.16 256.67 6.38 124.55 108.17 13.14
5/29/2023 16,371,148 13.52 256.67 6.38 124.55 108.17 13.14
5/26/2023 16,371,148 10.53 256.67 6.38 124.55 108.17 13.14
5/25/2023 16,371,148 8.86 256.67 6.38 124.55 108.17 13.14
5/24/2023 16,371,148 9.56 256.67 6.38 124.55 108.17 13.14
5/23/2023 16,888,787 10.66 256.67 6.58 124.55 107.66 13.56
Two observations:
1. It's fairly common for clinical stage life science companies to rally into approvals, so long as they are reasonably likely. My view is approval is highly likely but ...
after talking with several sell side analysts, there seems to be significant skepticism among institutions. In short, many didn't like the trial design where comparisons were vs dosing schedule that is atypical currently (though this dosing schedule was an approved regimen). I add this "skepticism" color just to be sure folks understand both sides.
2. On May 15, 2023 OTLK terminated its at-the-market offering agreement, with H.C. Wainwright, moving it to BTIG. Could it be the HCW affiliated hedge funds comprise much of the large short position?
Market Date 5/19/2023
Short Interest (Shares) 16,888,787
Days to Cover 27.96
Shares Outstanding (MM Shares) 256.67
Short Interest % SO 6.58
Float (MM Shares) 124.55
Float less SI (MM Shares) 107.66
Short Interest % Float 13.56
I'm very long the stock, having added in the Dec 2022 deal.
Up, the next significant move in the stock is.
- Yoda
I have no insight on the 3M.
If it were "revenue" they would also have to show some "cost of goods", which they don't.
"Research and other" -- while it's shown in the revenue section -- is more like a gross profit number.
Correct that we can’t impute the number of treated patients from the single line item. Some educated guesses can be made, but nothing conclusive.
Although, I don’t really think it’s all important because we’ll soon enough know the results of the MAA.
Auditors are fine with it. The don't call it revenue, so seems okay to me.
Yes, but also remember revenue is not shown. Rather revenue * gross margin is shown. And gross margin is typically low when scale is low.
My guess on billing profile:
- an amount is invoiced upon lysate manufacture,
- some additional amounts for shots in 1st year,
- in subsequent years additional amounts for boosters.
this profile will give rapidly increasing gross margin with increasing scale and as new/existing patient mix changes.
The R&D revenues were fine, if one has a reasonable estimate of the business model.
You do have to consider gross margins at lower scale are less than at full production scale and that some fees are incurred over time.
People hold different opinions on most things. It turns out doctors are people too. The docs that know DCVax best, think it works. Maybe they’re biased. Among other docs, who are less familiar with the therapy, some would like to see it approved and some wouldn’t. Some have conflicts but some, I’m sure, just aren’t convinced.
Regulators review data and try to decide if the therapeutic benefits outweigh the risks. It turns out regulators are people too. They are also swayed by political winds and by how desperate patients are for treatment for unmet needs.
The UK would like to be a leader in cell therapy.
Patients are desperate for better treatments.
The UK regulators granted the MIA license.
The opinions of the UK regulators are what count now. All else is noise.
I don't anticipate that.
I don't know if they'll press release it. Since so many are gunning for the company, management plays defense w.r.t. what they press release to avoid lawsuits.
I think a completed filing of the MAA is a factual statement and would urge them to press release it. However, if the MHRA then requests some additional information, should they press release that too? What if it seems like an immaterial request?
It's not without risk but I'll let them know my opinion.
yes, that's a decent estimate.
yes, I did mention that a bit ago, that my timeline estimate has shifted a bit.
I've also heard some other commentary (not from the company) that makes me slightly more bullish on how the MAA will be received.
Then I conclude I have half a brain.
Also had lunch with the chair of the Neurosurgery Department at a top 10 US hospital. He was not involved in the trial but was quite familiar with DCVax and Liau. He also believes the therapy works and should be approved.
I spent time with Dr. Mulholland, who gave the NYAS presentation. During our 1-on-1 conversation, he said, in his opinion, the data prove efficacy and safety. He expects the MHRA to approve.
all the stuff you can safely ignore.
Yes, all us marshmallow kids waiting for Wonka to hand them out.
I agree with the dates you circled. I don't have any better estimate but, in my view, soon is a good enough estimate.
According to the MHRA guidance², the MHRA offers a 150-day assessment timeline for all high-quality marketing authorisation applications (MAAs), aiming at accelerating the availability of medicines for patients in the UK. Under this process, the MHRA will evaluate the application for a UK, Great Britain (England, Wales and Scotland) or Northern Ireland marketing authorisation and reach its opinion on approvability within 150 days of submission of a valid application². However, this timeline may vary depending on the type and quality of the application, and whether any additional information or clarification is requested by the MHRA during the assessment².
Alternatively, applicants can use the rolling review route, where they can submit modules of the eCTD dossier incrementally for pre-assessment by the MHRA rather than as part of a consolidated full dossier submission³. The rolling review is intended to streamline the development of novel medicines by offering periodic enhanced regulatory interaction and advice to reduce the risk of failure at the final phase³. The final phase of the rolling review should be completed within 100 days in two stages as 60 + 40 days with an intervening clock off period¹³. However, this timeline may also vary depending on the quality and completeness of the submitted modules and data³.
Source: Conversation with Bing, 4/22/2023
(1) 150-day assessment for national applications for medicines. https://www.gov.uk/guidance/guidance-on-150-day-assessment-for-national-applications-for-medicines.
(2) Marketing Authorisation Application submission dates for 150-days .... https://www.gov.uk/guidance/marketing-authorisation-application-submission-dates-for-150-days-national-and-european-commission-decision-reliance-procedures.
(3) Rolling review for marketing authorisation applications - GOV.UK. https://www.gov.uk/guidance/rolling-review-for-marketing-authorisation-applications.
(4) Rolling reviews: a useful tool to speed up the regulatory review process. https://www.vennlifesciences.com/wp-content/uploads/2021/04/Speder-Bruno-Rolling-Reviews-Feature-May-2021.pdf.
FDA submission doesn't have to be after MAA approval, but the FDA decision definitely will be. UK approval obviously makes the FDA decision easier since regulators are people, and their decisions are based on more than a strict review of data and trial protocols (which is the bear case). There are many examples of imperfect trials being approved when the need is high.
There's not going to be a bankruptcy. I'm confident the company has access to sufficient capital.
I agree one should always consider risk as well as upside. Filter out all the noise -- most of what gets discussed -- and just make one forecast: what are the odds the UK regulators approve the MAA? That's 90% of the risk and 90% of the reward.
What's the timing of the MAA submission? Soon, but it's noise. No opinions should change if the filing is May or June.
Will they get regulatory approval in Canada? Correlated with UK approval, so stay focused on UK.
Will they get regulatory approval in US? Correlated with UK approval, so stay focused on UK. Timing? Noise
Will we see combo with industry partners? Correlated with UK submission / approval, so stay focused on UK.
MAA approval changes everything. Company value will discount all the above and more. Easier access to institutional capital. Easier to negotiate attractive combo partnerships. The company will jump onto the acquisition priority list of several big pharma cos.
...and, upon UK approval, Feuerstein will Tweet...?
I can only say I'm in favor of as many combo trials in as many cancers as possible, run efficiently and timely. I suspect that gets done by one large company, but other approaches are possible.
correct but I've also admitted that one is a little harder forecast. I hope to tighten up my forecasts shortly.
I was definitely referring to the MIA.