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I wonder if that's all of them.
This is accurate.
A follow-up to my prior comment.
I'm not a cheerleader for my investments. I will be honest with people about both the promise and the peril. So, if anyone took my last comment as unduly negative, I want to be clear. OTLK is one of my favorite longs.
The pricing risk in wAMD is nothing new. I considered it when I first established my position at $1 and I don't think the pricing risk is evolving differently than I first expected.
My target is still $10. If I believed what management is telling me about their hopes/expectations my target would be higher.
I've heard from docs that faricimab is quite good and they expect to transition many of their patients currently on Eylea to faricimab.
So, Eylea will be pressured by faricimab and biosimilars. Pricing will come down. Biosimilars will price at 60% - 70% of Eylea, or around $1000 or perhaps $800.
But the need for cost control in healthcare isn't going away (e.g. the use of step edit protocols). The regulations that will cause doctors to stop prescribing an off-label drug when a comparable on-label is available isn't going away. These are the key realities behind my OTLK forecast.
I ask myself, what's my margin of safety with OTLK? How wrong can I be on my forecast and still be right on the stock? I find that to be, still, a very wide margin.
yes, agreed
yes, meant to indicate we are still large investors, pretty much what we were before.
yes, i agree
The medical community well understood that PFS was not a good immunotherapy endpoint years ago, while the trial was ongoing. We can debate if NW knew that their PFS endpoint failed or if they came to understand that PFS wasn’t a good endpoint. I don’t think that is the issue.
What matters is if NW knew treated patients were living longer before the new SAP was determined.
One can say that they knew the placebo + treated were living longer, but that’s not the same thing knowing if the treated patients were living longer.
Longer than expected blinded survival can also a result of inclusion criteria or some other random circumstance.
One could look at the data and see if there are clues that might clarify. I think the clues are there.
I sort of feel like every issue with w.r.t NW has been beaten to death by all sides. I try to show respect for those who think it is a failure. I don’t think the points you and others make are without merit. I think they are often without context, but not without merit.
I have no desire to convince you or others of my views. I understand what you are saying. I just think there are some nuances that are being missed. But, hey, what do I know?
My brother is still alive, though he is not cured. He has commented that Dr. Subbiah believed the treatment provided benefit. However, I'm the first to say one data point proves little.
Our position is NW is large and include common stock and warrants. Some new investments were made, and some warrants were exercised, both with cash and cashlessly (which reduces the number of as-converted shares held but not the investment value of the position). I have not asked others in my circle what they hold but, judging by the questions I continue to receive, I estimate our collective position is +/-10% of what it was two years ago.
I don't have a position in Advent.
I don't think PFS matters anymore. Medical practitioners have come to understand that.
I disagree with those that say a PFS failure mean a trial failure. It is true that one can't pick an endpoint after peeking at the data. That is not the same thing as selecting different endpoints while being blinded to the data with respect to those endpoints.
I also believe that regulatory approval of a therapy is not a purely statistical exercise. I am well versed in the red flags of failed trials, but decisions get made by generally well-intentioned people that consider the full context of information. I try to do the same.
I am sorry to read that some feel my postings are unethical. A few thoughts:
1. Investing is my job, and I’ve made a good living at it for decades, so my general knowledge base is pretty good, but I don’t know everything.
2. I supply capital to companies, so my company specific knowledge base is usually quite good. This is typically my biggest edge.
3. I post on investment boards on occasion because I believe it may be useful for some know how I think about Northwest Bio, Outlook Therapeutics, etc. Again, I don’t know everything, and I get things wrong sometimes.
4. What I won’t do is write something I don’t believe. A caveat to this is that I don’t write everything I know.
5. I don’t want to influence others to buy a stock I’m long, so I can sell it to them.
6. I don’t want to influence others to sell a stock I’m short, so I can make an advantageous buy-to-cover.
7. Both #5 and #6 are unethical. No thanks.
8. I don’t think there is anything wrong with being short a stock. If right on the fundamentals, being short (because it slightly depresses the price), keeps longs from losing as much money as they will without the short. What one will not find (during the period when I was short) is a post from me trying to scare people into selling.
9. If some feel I’m imploring them not to sell their long, I didn’t intend that. On several occasions I’ve highlighted the risks. On occasion I complement bashers for a making a valid point, though it would be wonderful if they would add some context. The only thing I remember imploring people NOT TO DO is to put their last dollar in the stock.
So, that’s how I view it. Take it for what it is worth.
So, which is it? Journals are slow to publish -- or -- does the time it takes to be published signal failure?
Inconsistency bothers me.
Cavalli Picks
@cavallimedia1
Feb 22
Will be huge when publication hits. Problem is could take another year. Publishers like NEJM are notorious for taking YEARS to publish important papers.
but just now says:
Cavalli Picks
@cavallimedia1
$NWBO press release projected ONLY SEVERAL WEEKS to TLD from DATA LOCK. Over 17 months signals likely failure!
yes, still upbeat.
I'm going to go do some other things, but I'll check back from time to time.
Best wishes to all.
I was concerned about PFS and thought the valuation was too high at the time (thought the pace of the trial would disappoint).
I had given them capital earlier but wasn't at that point the time.
Even when I'm short, I never spread F-U-D. Fundamentals generally win out.
I also never promote names I'm long either, for the same reason.
I think we will see TLD sooner than "ever"
I'd refer you to some of my earlier posts the company's timeliness.
Sure... a classic red flag. I'm not an idiot. I've worked in the hedge fund industry since 1994. Shorted a 'zillion' stocks, including NWBO at one point.
A red flag is cause for investigation and a fair evaluation of the entire mosaic of information. You've had some decent points over the years, as I recall. But I'm not trying to win a college debate. I'm just trying to make a few bucks (and support companies with my capital that have a shot at improving peoples' lives).
I have a 'pile' of NWBO warrants, a pile of NWBO stock, but no position in Advent.
There is nothing I know of fundamentally that would justify a sharp sell off.
The broad market is obviously choppy, people are tired, and some here (and on other social media) put an odd amount of effort into making fallacious bear arguments.
Bear arguments exist (any stock has them) but everything I've read recently is b-s.
Did somebody yell fire?
OTLK acting incredibly well.
got it... an OTLK buy-out is possible. I think there have been discussions before and, for a strategic that already has the right sales force, the economics of adding a high margin product will be compelling.
We could see something before an FDA decision but, if early sales ramp as I expect, OTLK will be hard to ignore.
My peak rev assumption is $1B but it is possible to get to a $2B number if the stars align.
H2R, sorry I didn’t respond… I haven’t been on these boards for a month.
I think it’s too early for buyout negotiations. Although I can see a very large potential market for DCVax, I can also see other questions that have to be answered before large pharma steps in. They are very risk adverse. That said, I’m not bothered by that at all. I really never think about buyouts. They happen when everything is going well but I just focus on if a company is trending toward doing well, which is certainly the case with NWBO.
W.R.T. 9 meters biopharma. I own it but I’m not buying more down here. Once I have a relationship with management (which is the case here), I tend to keep a least a small position and stay in touch in management. If something changes, I’ll notice and scale up.
Glad to see you here in OTLK. Institutional investors are skeptical, thinking ONS 5010 won’t get much penetration, but management very optimistic. Step edit programs / health care cost issues aren’t going away and the next innovation isn’t changing that.
I agree that the fate of DCVax will not just be a result of statistics, the SAP, or the arguments over of endpoints, etc., etc. The regulators and the docs are people who care about their reputations. Reduce risk to reputations and likelihood of success increases.
Wish I could help more.
I come from the large hedge fund world. Too much detail is unwise.
I don't think someone with an advisory relationship would make a good peer reviewer.
I still maintain my earlier Stupp opinion.
A friend of mine accumulated over 20M shares around $0.20. He seems happy...even asked if I wanted to meet his (divorced) sister (not kidding).
I can say this now... why? Because he has updated information.
From what I know, that's a real possibility.
Ex, what would change your mind?
…and make it real. We all know they are comparing vs external controls.
Is there any hazard ratio or p-value that would give you pause?
Does the prestige of the journal matter?
Any nuances in the data?
Anything?
For those who don't know, I was short once (w/ legit borrow).
There was a time that I too thought the data was bad for pretty much the reasons you state.
Important to continually seek out information, check assumptions, and be willing to change views if information changes.
well put
For a number of years I had a quant fund run by a set of PhDs and comp-sci guys. We excluded small cap life sciences for just that reason.
yes, that's it, thanks
I replied but it seems to have gotten dropped. Not sure what happened but, in short, I'm adaptable and will do anything provided it's legal and profitable.
and I wouldn't be surprised if certification is near
unfortunately, the sector always impacts an investment in just the kind of ways you describe. The finance professors like to express it in betas and residuals, but it's intuitive for everyone else.
However, one point I keep in mind is that for small companies the stock/company specific drivers are proportionately way more important, and for an investment like NW, way, way more important.
This is the reason that I am okay going over the falls in a barrel. The poor recent performance in the stock is best explained by all sorts of things other than the trial data. Everyone is tired, some people have problems elsewhere in their portfolio, some hit stop losses... My answer wouldn't be complete if I didn't acknowledge that someone could have leaked info. But I think that is a very remote possibility. I can't say for sure, but I have reason to believe that if data were leaked it would be a positive.
I do think we have to accept that, if the data are positive, the stock price reaction will be more muted, and our reward will be drawn out over a longer period.