Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
DrChuck: The Pinnacles were great!
Very glad I went. It was a lot of sun though. I am wiped out, I think from the sun. We hiked early enough that it wasn't super hot, but it was very sunny! I'm too old to make that mistake.
We had a late lunch in San Juan Batista afterwards. Nice little town. Hope I can afford to stay in the south bay Dr.Chuck, but I don't own a house. Maybe if things go right here, but the rest of the planet is looking pretty cheap.
Great news to me BBKING:
Given my stated concerns about early crossover patients, your post about a 3 mo crossover patient doing well on DCVax-L is a relief! Of course there could be different reasons for early progression, but 1 out of 1 is batting a 1000 for now, for DCVax-L. Thank you for that info.
Afford: Burnanka made some sense to me regarding the DMC being in the employ of the sponsor, Northwest, and Northwest having the ability to communicate with them on any matters that do not threaten the trial blinding. It made sense but it was a wakeup for me. I was not looking at it that way prior to his post, but I don't know why.
Chiugray: One of my worries has been that the Temador is enough of a problem for some patients that they will not crossover well.
Temador is known to damage the immune system to some degree. I worry that there is a wide range of sensitivity to Temador in that regard, and that many of the early progression patients progress because of an early drop in immune system strength. I worry that those patients' immune systems may be too damaged for DCVax-L to work well. If that is the case, they need to come up with an early warning system to cut back on the Temador early for those patients and crossover.
I worry also that these crossovers not performing well could make DCVax-L look ineffective, when in fact, that is not the problem.
I know Flipper has talked about DCVax-L healing the damaged immune system, but I haven't seen any articles stating that. Not saying the articles/clinical don't exist. Just saying that I have not seen them.
I hope that if they see this in the clinicals they find some way to figure out that it is not DCVax-Ls fault, if that is the case.
Off to my hike in the Pinnacles!
Flipper: Sound Judgment?
There are a lot of people counting on your sound judgment Flipper. Your disclaimer is surely a needed recent addition.
But I think a stronger warning would be your complete lack of judgment in refusing anger management and medication in order to save your relationship with Jennifer Connelly. Any man who would not go to any length to stay with that woman can't be all that bright. IMHO
I'll go do something else, since I seem to put a damper on the board in the afternoon... but one last comment, maybe for the day;
If I were to rehash the logic on the possible explanations for what is going on, I would go back only as far as Germany deciding to not have a trial with a placebo. Maybe that means they are not going to have a trial, or maybe that means they are going to have a trial without a placebo.
That would be my starting point. I think that the arguments I have made and heard convince me of that much.
Most paths from there look positive to me, at least in the long run, though there is at least one bazaar, super unlikely negative path.
But I would start from there and work through all the possibilities. But I am not going to.
Swamprabbit:
I am all in, so obviously I think your step-dad will do well. But I don't want to tell you who I recommended to my Doctor the day before they took a giant dive. I hope I don't get sick for a long, long time. That's the thing about recommending stocks. I also recommended Northwest. Hopefully that is the name he remembered.
On the other hand, when I recently decided Northwest was ripe, I excitedly called an old friend, trying to help him out by recommending the stock. He blew me off. The next morning they announced the German decisions, and it rose 50% in two days, peaking at 75% before it got undermined.
We should be careful about teasing Flipper. He may wear rose colored glasses sometimes but he comes up with more good info than anyone else on this board. We don't want to piss him off.
41 Days for FDA after DMC on Provenge
That is the number I remember anyway. The DMC had recommended early termination due to efficacy. But hard to know how well that situation relates to this one. The DMC might have just asked for clarification of a rule or asked the FDA to create a new rule to handle a situation identified that is not covered by the rules.
But in fact: If it has been 14 weeks since the DMC started the review, and the original estimate was 6-8 weeks, then we are 6 weeks past the original estimate. That's 42 days, with the holidays adding some easy explanation for further delay. But the 42 day number brings one to Flippers question about announcing news during trading, mid-day.
Someone recently posted here that a stock they once owned announced trial results mid-trading day. They said there was a halt announced on the stock, then the good news.
I don't believe that Northwest would cause a halt to trading, with all the attention it would generate, for bad news. But it makes sense to do it for good news. And a Friday might make sense.
I think Fridays used to be the best day for good news because so many people got their stock picks from reading the Sunday Finance section of the paper. Ie looking at the stock rises for the week, then reading articles about the stocks that stood out. I don't know if that is true anymore.
Swamprabbit:
We have all expressed out deep concern for the elderly. You need to do something for your step-dad. I would suggest reading Flipper's posts to him at bedtime each night. That should offset this terrible psychological campaign by the Germans, and help him to sleep at night. I know it helps me.
Swamprabbit: Just when you think the Germans have become good guys!
We Can Help Bolster the World Markets.
There has been a lot of volatility due to the Russian - Ukrainian - Crimean situation. And today was the original date for a cease fire of sorts to end. The Russians have said some positive things this week that have the world markets feeling ok... but again, that cease fire or whatever they called it was to end today, and their are reports that Putin's finances are now in danger of being frozen.
So the weekend is a little scary. But there is something we could do about it.
Flipper and Etienne need to try to talk the Canadian Olympic hockey team into giving their gold metals to the Russian team, while us American's need to petition for a review of that controversial (dubious from what I saw) technical that ultimately gave the match with the Russians to the Americans.
The Russians take hockey very seriously!
Foxhound: Caregivers can be drained in big ways. The statistics are pretty extreme. I was lucky as a caregiver to my mom because my dad insisted on doing most things until his final few months. I was mostly a backup. I hope your sister does recover at some point.
As for the failed ALS therapy... aren't we better positioned here due to the compassionate use statistics? I don't know the numbers on compassionate use, or the patient profiles. I know Flipper knows. Maybe you remember these things too Foxhound, or John or OU or others.
There was compassionate use in Israel, which has been cloaked to a large degree for some unknown reason. We have the one patient interview that is famous and very positive, but I don't think I have seen any stats. Maybe those stats are not public due to standard patient privacy laws, in spite of being outside of the blinded clinical. But what of aggregate stats? Those would not be protected, would they?
We have Linda's statement about an 80% response rate... I don't remember if she was addressing the compassionate use or the P1 + Compassionate use. And I don't know exactly what definition she was using for response. Not necessarily 6 mo PFS over SOC.
And there is compassionate use in the US also, right? For how long? In the UK, right? What are those numbers?
Sentiment has waned, but overshot?
There seems to be a real dip in sentiment. Maybe that is good to reel in the over exuberant ones with leveraged positions... But what has really changed since the celebrations a few days ago when the documents concerning the FDA-PEI data sharing policies were uncovered? Nothing. Nothing has changed.
The negative possibilities were always out there. Cognate is the perfect hedge for Linda and whoever else is invested, if immunotherapy is the up and coming thing. Cognate doesn't need NW. And Cognate would be easy to sell. Very easy to sell. So, it is a scary elephant in the room, but...
Whether Linda Powers paid for her shares or not, it is still an enormous amount of money lost if Northwest does not succeed. And while she may be 70% business, I think she is a bigger than life personality so that 30% humanitarian is still more humanitarian than many humanitarians. I think she would very much like to put Enron way behind her by accomplishing something big and beautiful. And she has built in massive amounts of contingencies for Northwest. Not just a fallback to Cognate. It's not a plot.
Afford: You learn a lot about people as they respond to their parents' difficulties in their final years.
A common experience in classical fiction, in historical non-fiction, and unfortunately in real life, is to have to watch your siblings descend in some way on your waning parents, anxious for faster and more sure access to inheritance. Something very disturbing to watch. You sound like the opposite end of that spectrum.
Frustrating too is watching negligence in hospital care for the elderly. Certainly the elderly are not a priority over youth, and some complacence on the part of staff may be unavoidable, but complete negligence is terrible.
But selling a bad therapy to a patient, that puts them in pain for an extended time is of course much worse than negligence. I am sorry that you had to witness that, and I don't think you should kick yourself in any way about it. There is a suffocating effect of having a large number of people, including MDs all aligned in one direction. It is hard to describe. Family members can have the same effect, which is paralyzing to the part of you that feels something is not right.
While the Doctor Kevorkians are sent to prison, the evil offspring of the Lions in Winter go unchallenged for their horrid deeds, on a daily basis.
And what you describe is even worse. Because while these other horrid deeds, however disturbing, in some ways, fit roughly into the category of Eskimos floating their elders off on ice-bergs into the netherworld. Something for the good of the whole. The grandchildren. While the things you describe with forcing debilitating chemo down a patients throat has no underlying natural basis.
But keep in mind that not all chemo therapies create the kind of side effects that you describe. Some are very effective. Some have few side effects. And some have both of those positives. Some will likely prove to be useful adjunct therapies to immunotherapies.
#6694 Pyrrhonian? For Real?
Last time AF projectile vomited his bile we had some warning. I think it was from some tweets with Smith.
Was there really some indication he was about to spin his head 360 and blow green chunks again?
Nice! John on Direct Dev Patent Useful for L+Prostate.
So we haven't seen anything yet, and we are already getting great results!
2 Yrs Ago NW thought Trial Done by Now.
Two years ago when Northwest first applied for the hospital exemption they thought the trial would be done by now. So... was the application just a contingency, or would the approval have had meaning even if the trial had been completed already?
The exemption allows foreigners to buy DCVax-L treatment in Germany. That would still be a positive if the trial had been completed by now. So, if they knew the response to the application could take a couple of years, maybe that was the plan at that time.
But now that approval would actually be a problem for the ongoing German trial... the PEI would not have approved it if they did not know somehow that there was no conflict due to the lack of the need for a placebo for the non-pseudo-progressive group in the trial. The lack of that need either due to an FDA/PEI mandated crossover of the placebo or a discontinue of the trial due to efficacy.
So, I now feel ok about wasting everyone's time going in circles on this. This is a little convoluted, but I don't think that this or the explanation for the insurance reimbursement situation are at all unreasonable. They ring true for me, so once again, I am lifting my hand off that pile of chips I have riding on red.
Ok I see an explanation.
"But regarding the apparent conflict between the German trial and the German hospital exemption, I do not see an explanation for why NW would have applied for that exemption years before the interim review, and thus years before they could possibly know that the data would be good enough that the conflict would be moot. I would certainly agree that it seems very unlikely that they would deliberately or accidentally setup a future conflict for the German trial, but that is the only reasoning that I see to rely on. I don't see what your arguments about Direct do to solve the mystery of why they were not worried about this apparent conflict. Certainly Germany would want to get in on the ground floor if they saw Direct being huge from years back, but... why would that mean anyone would want to risk a future conflict with the trial via the hospital exemption?"
I suppose Northwest could have applied for the hospital exemption years ago, knowing it would take years to get approved, with the expectation that the German regulators would not approve it if a conflict for the trial existed at that future date. That is all I can come up with. But the branches are getting skinnier as I move up and out. Hope you had a better model that I missed.
I don't quite follow Flipper:
There are two changes to the German rules that present a possible interference with the German trial. One is the hospital exemption, because the assurance that you would receive DCVax-L and not the placebo. The other is the insurance reimbursement, because for a German going outside of the trial via the hospital exemption, there would not be the added financial burden.
I see a good explanation for how the insurance reimbursement came about in spite of this apparent conflict, assuming the german regulators had access to needed P3 data. The hospitals requested the insurance reimbursement, not considering the conflict with the trial, and the regulators held off on their decision until they knew from some form of P3 data that the issue was moot. Moot either because the trial will not continue for the subgroups to be included in the German trial, or because it will continue without a placebo (assuming there is such a modality).
But regarding the apparent conflict between the German trial and the German hospital exemption, I do not see an explanation for why NW would have applied for that exemption years before the interim review, and thus years before they could possibly know that the data would be good enough that the conflict would be moot. I would certainly agree that it seems very unlikely that they would deliberately or accidentally setup a future conflict for the German trial, but that is the only reasoning that I see to rely on. I don't see what your arguments about Direct do to solve the mystery of why they were not worried about this apparent conflict. Certainly Germany would want to get in on the ground floor if they saw Direct being huge from years back, but... why would that mean anyone would want to risk a future conflict with the trial via the hospital exemption?
Didn't Linda (Powers) recently make the consoling statement that everything was on track for the P3 trial?
If so, it rules out things known by her, if you trust her on such a statement. I would trust her on such a statement. However, many of us have been arguing that she probably is not privy to everything that is going on with the P3 interim review.
Exemption vs Reimbursement?
Are you saying that they will turn away patients that fit the trial requirements? They do that now for compassionate use I think. And the hospital exemption looks like compassionate use to me. So maybe that is right. But I did not get that impression from the PR.
The reimbursement is to be considered on a case by case basis, but I thought the hospital exemption was open to literally anybody with the money to pay for the treatment.
"It means that people with money could get treatment and those without money would have to risk placebo."
He means foreigners without big $ coming to Germany for treatment (as did I). Those would be the only people joining the German trial.
Foxhound: So these recent theories on what went on require only an explanation for the delay for the pseudo-progression group. Flipper has an explanation. Maybe yours is also a good possibility. But it could be for just that subgroup.
Assuming there is such thing as a trial without a placebo.
I gained the impression that the Europeans sometimes have trials without placebos from posts that I read on European blogs in response to news about the DCVax-L trial starting in the UK.
Not much for me to have built on. Does anyone know if the Germans do sometimes have trials without placebos?
Because I don't understand what would happen in Germany if the trial ended early (in a good way) with FDA approval. The trial was to be joint, but if Germany never got started, would they just approve based on the FDA decision? People have argued that even within Europe, other countries would not give a full stamp (beyond insurance reimbursed compassionate care) based on a German approval. So how could they do so based on an FDA approval. And so, how could Germany?
But I am sure I have heard of trials in the US continuing toward the end with semi-approval from the FDA where they crossover the placebo group and are allowed to sell the drug but remain under scrutiny of the FDA till some set threshold is reached. In that mode, Germany would do likewise with no placebo. Then no conflicts with the insurance reimbursement in Germany.
Makes sense to me Pyrrhonian. Not sure what I was hanging on.
I had concluded that Northwest would have to have given a nod on reimbursement long ago, but would not have, because they would not have known long ago, with any certainty, what the data looked like.
But reimbursement isn't Northwest's call, as much as it would effect them. It is Germany's call. And so Germany would be the ones to need to know that there would be no need for a placebo for the non-pseudo-progressive group in order to allow reimbursement. Wrong German agency... but I personally don't care. There may be the same data share agreement with this other agency.
The request for reimbursement by the hospitals created a possible future conflict with the trial, but the hospitals would not be thinking in those terms. The agencies approving the request, would, however be thinking in those terms.
At any rate... that does all fit. So thanks Pyrrhonian.
Signed Mr. Howell (again) thank god... though I always liked Gilligan better.
Mumble mumble mumble...
The PR says that the Hospital Exemption / (sounds same as compassionate use to me) side of things was in consideration for 2 years in Germany. The recent PR does not say if Northwest requested this, but I remember Linda Powers saying that they had been back and forth with the PEI on it. PEI had requested further info, etc.. So, that was apparently initiated by Northwest.
However, the recent PR says that the hospitals requested the reimbursement. It doesn't say when.
So, Northwest did not request the reimbursement. Still, I don't think the Germans would land that (reimbursement) in Northwest's lap if Northwest was not good with it. So, why is Northwest good with that when apparent conflicts exist for the trial in Germany, if the trial is to have a placebo? To me, that is a mystery.
This is all probably restating Afford's original question. In fact, I think we were also here some time ago. I see why we moved on to other topics. It is confusing.
Again, it all makes great sense if Northwest knew that a positive halt for efficacy, at least for the non-pseudo-progressive group, was in the bag and therefore felt comfortable giving the nod on reimbursement. But there is no indication that they knew that. But I don't think any of the negative scenarios make sense either.
Afford: German Clinical
Back on that logical thread. How could the German clinical continue as it currently is structured, with a placebo, if they are soon offering DCVax-L to all Germans without the placebo?
Their trial would have to be built on all foreigners who did not have the money to pay for the non trial path. I don't know how likely that is, but it doesn't sound right. It would certainly put pressure on all the other countries to allow insurance coverage.
On the other hand, the German hospitals full reimbursement from insurance was pursued some time ago. Did someone say 2 years? I don't know about that, but if it was before December 2013... then it's not like NW would have proof in hand, yet, that there was going to be an early pass for efficacy.
Northwest has to sort of approve these plans. In fact, they submitted requests for part of these German changes. The other requests were submitted by the hospitals directly... I think. Which part of the requests did NW submit? Basically compassionate use? Then the hospitals applied for the insurance coverage?
I just don't believe that a plan would move forward in Germany that could be a problem for NW. I don't think there is that much chaos in the plans. But Northwest could not have known with great certainty that all was well. They could have known with more certainty than any of us, but not enough certainty to allow Germany to move forward with a plan that would hamstring the trials. So... something is wrong in my assumptions. I will have to check my facts. That won't happen quickly, so if people chime in it would help. But what changes to the German policies were petitioned by NW and when, and what changes were petitioned by Germany (I think German individual hospitals), and when?
Hodge: Or end for the non pseudo-progression subgroup. Ie halt for efficacy. Then there is no German trial.
Ough!! That's not true. Germany would still want a trial. But it would seem that it would have to be without a placebo.
Flipper: What was that recent example where the FDA removed a placebo late in a trial but the new data would continue to be forwarded to the FDA and the FDA would retain the right to change their mind until some date or threshold?
Hodge:
There is a difference, perhaps just unstated. But while the cost may be moderate compared to other treatments, it is still a lot of money to many people. And Americans would not be covered by German insurance. So not everyone would have the luxury of getting assured DCVax-L in Germany.
That said, there would still be a lot of migration. Still harder to finish in the US, and as you and Flipper agree, apparently impossible in Germany.
And Germany was to be a big chunk of the final numbers.
So... either the situation is FUBAR or... there is already an agreement in place that the trials will continue without a placebo for the non pseudo-progression subgroup.
And that might be a problem for the placebo effect if patients know whether or not they are classed as pseudo-progressive. No... even then, they have gained no new info about their situation.
Interesting no FDA needed for Safety + call.
It would seem to be right up the FDA's alley. But I am sure there is a good reason. Not saying NW is an exception here. Probably standard.
Mingusahum: What if the German info gained was disposition by the FDA?
I can see your point if the Germans made their decision based on data from the trial before the FDA made a decision (on the relevant subgroup(s)). Because in that case the German approval would put pressure on the FDA during their decision making. For the FDA to feel any public pressure, or perceive any public pressure in that decision would be improper.
But let's say the FDA actually already agreed to approve the subgroups that the Germans cared about. Then there would be no pressure on the FDA as a result of the German announcement. I don't see what other considerations there would be in terms of effects on the trial. I don't see how that reveal would effect the trial in any way that anyone cares about.
The provisions you are citing have to cover a very large number of situations. I believe they allow paths for the FDA to deal with improper action, but I don't believe they require the FDA to take action against any violation, because they are too terse for that.
When I said that I thought the FDA is concerned about companies not wasting money in trials I was thinking more about competition. For example: If company A spends $2B on a trial and puts a drug into market, then allowing company B to suddenly bypass the same scrutiny with a slightly better drug is a difficult scenario. In human terms, any improvement should get out there as fast as possible. But in practical terms, if the FDA allows that, companies will be less inclined to gamble money in R&D. That is one of the fundamental standing catch 22's in the ethical end of things.
Maybe not a "catch 22". What is the best term for that? Ironic? FUBARidasic?
Afford: Yes for Germans, no for Americans.
The subjective, qualitative information from patients and physicians might be a big part of the decisions for the recent German approvals, because those decisions don't have strict guidelines (I don't think). If so, that is partly what makes that semi early approval modality so important. Sort of non-linear decision making that can prevent very sophisticated bad decisions.
But I don't think the FDA has that leeway. Unfortunately, I think they are stuck with the numbers... well not entirely, but to a far greater extent than the Germans in their recent decisions.
One other big difference that I think you mentioned has gotten little mention in recent discussions. That is the compassionate care data. That is both qualitative and subjective data as well as hard objective data. I don't know how many compassionate use cases are out there for review. I made a guess some time ago, and should not have. My memory of readings is not good enough. I did recently ask Northwest if they had a number for me. I don't think I will get a response. They have been nice, but they are probably overwhelmed at this point.
But the Germans had that data to look at both subjective and objective. And I believe it was a lot of data. So, maybe they didn't need any P3 data or interim recommendation, but it appears to me that they did wait for it.
Mingusahum: Seems backwards to me.
That the Germans took 2 years to make their decision means the coincidence that they finally made the decision simultaneous with the end of the typical DMC review period less noteworthy?
Extend it to 200 years. If they contemplated things for 200 years and then made their final decision within days of the expected end of the DMC review period... the coincidence would be that much more noteworthy, not less noteworthy. Seems to me.
Mingusahum; Are you sure that the FDA policies are that concerned with investors? Your main reason to discard these speculations about the PEI getting P3 Data from the FDA seems to be that the recent announcements from Germany would then clue investors about the data.
The FDA has to concern itself about issues that could make expensive drug development efforts a waste of money. So they definitely do involve themselves with investor issues. But this is a little different context. I don't see why the reveal by the Germans that you are concerned about would be a concern to the FDA. And in what way would it un-blind the trial as you or others have argued? That the drug seems to work does not have any more placebo effect on the control group than the experimental group.
Foxhound: Like the analogy, but...
I really like your comparison of complex explanations for how the Germans could have gotten P3 data to an excess order curve fit to data.
But maybe, the motivations for these complex explanations are the 0th order gut feel. The Germans were late in moving forward with their trials. Very late. And we all talked about why that might be. It seemed likely they were waiting on the DMC recommendation, and or the data. That is what I felt made the most sense, and that is without any complex explanation.
Then the Germans did move forward with things right at the time the data was being examined... rather, just after the end of the period typical for a review. That just seemed to line up too well with their decision being effected by the data, the aggregate data, or a communicated disposition by the DMC or FDA.
That is 0th order, and that drove all these complex explanations...
The complex explanations are just to keep us from having to buy Tums.
Nice post Pyrrhonian! On PEI-FDA possible data sharing... ie how that could happen and what provisions allow it, etc..
Flipper: 2015 Cancer Film looks great! Definitely look forward to seeing it.
I hope they continue working on the film long enough to include developments at Northwest, validated by FDA approval... but regardless, it looks great. It would seem likely that immunotherapies in general will be a large part of the focus.
Mingusahum: "Aggregate" Interim Data
I got slammed a couple of days ago for not specifying that in a post. Wish I could remember who slammed me, but at any rate, they were right. It is an important distinction. Like specifying "Fiscal 2013 Taxes", not "2013 Taxes" which is ambiguous.
The communication of Aggregate Interim Data is a very different thing than data detail. The person who hammered me was certain that there was not a risk of violating the double blind with the communication of aggregate data.
Did Cramer invent Adam Feuerstein as a "biotech expert"?
How and when did Adam Feuerstein suddenly get labeled as a biotech expert?
Was it when he started working for Jim Cramer at "The Street", which is owned by Comcast?
Feuerstein has deliberately done irreparable damage to a very large number of biotech companies over the years spewing not just unfounded negative garbage, but making knowingly false material statements in transparent efforts to reduce investment and thus stock price. All the while, Cramer repeatedly references the dirty posts while qualifying Feuerstein as an expert in the space. Note that Feuerstein has no biotech background whatsoever.
There is even a website created by fans for one biotech company in 2011 to try to do something about this viscous #$%$. That's at least 3 years of unmitigated attacks on biotech companies struggling to bring promising cures for horrible diseases to shore though nearly impossible P3 financial obstacles. Could you imagine making a living, taking your yacht out to these struggling companies and slamming them over their heads with an oar, over and over in public view, as they struggle to reach shore. And the SEC has done nothing about it. What do those guys do all day long?
Feuerstein is definitely a #$%$ doing very real damage in the biotech sector, and I believe he is Cramer's #$%$. And I don't think Cramer is going to be successful in his apparent attempts to distance himself from Feuerstein.
These two sharks, blinded by greed, have stupidly made the mistake of feeding in dolphin waters, and they are going to pay the customary price.
Why Comcast would continue a business relationship with Jim Cramer (and therefore Adam Feuerstein) is beyond my comprehension, especially given Cramer's own admission to crooked activities while working as the manager of his own hedge-fund, and his now public recommendation that all hedge-fund mangers do the same. Anything for a buck, and I mean anything. It's that simple.
(I saw the above recently posted on Yahoo).
Nobody has replied to the edited post:
When someone replies, ie makes any kind of comment, the posting moves back up to the top of the board.
Thanks Flipper: It just got reposted on Yahoo with a couple of minor changes. I predict it will float to the top all day long.