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I think this is right on. The trial was clearly designed originally to use PFS for AA, as OS is the clinical benefit sought in most oncology cases. I believe that for whatever reason, the PFS data would not support AA. However, very convincing blinded data on blended OS could absolutely serve as a surrogate endpoint for AA, allowing the trial to remain blinded indefinitely for confirmatory results on OS.
This is why the trial was not unblinded as previously planned at given event numbers. This is (part of) why the publication of blinded data has/is taking so long. And this is why they've gotten their house in order from a corporate governance standpoint. I hope to see this begin to play out in the next week, but I'll still be here waiting come next Friday if there's no news.
None of this excuses the lack of communication over time, although I suspect there are other reasons for that.
All in my opinion, of course.
Thanks for the explanation, and I understand where you're coming from. My point was simply that some may not read the situation fully, and in turn be unduly afraid of a R/S scenario when the circumstances were quite different, in my opinion.
As an interesting aside, blockchain is legit and will be a major contributor to many markets in the future. If you can figure out HOW to invest in it, you'll be a wealthy, wealthy man down the road.
That said, adding "blockchain" to your company's name and/or mission is a complete pump and dump move. You're correct there, and Newt's suggestion was ridiculous.
I'm genuinely curious as to how you think that could help this company grow its core electroceutical business. Or are you suggesting it just become a crypto company, or nebulously specialize in blockchain technology, instead of the area where it has focused and shown promise?
While all cautionary tales are useful, most should be taken with a grain of salt. Ocata (ACTA) was months at a minimum from releasing even Phase II data on its lead drug candidate when it uplisted. I'd consider that materially different from a hypothetical scenario where a drug has positive Phase III results, then uplists. I know which one I would be more eager to short. Not to mention, coming from a share price of $0.08 to the NASDAQ at a 1:100 split looks a little more like shark bait than if there were price appreciation to, say, $1 here prior to an uplist.
Edit: meant to link my source - https://www.bizjournals.com/boston/blog/bioflash/2015/11/ocatas-379m-acquisition-leaves-many-small.html
Again, not to say it's not worth looking at! The danger of shorts is very real, and I also own a tinfoil hat. But this particular story isn't striking much fear in my heart regarding a CYDY R/S and uplist following (assumed) positive P3 data. With P3 mono open label and prime for an update as well, I see much more protection here.
This is incorrect. The material you linked to is for "Continued Listing" standards, which means that the company is already listed. This is why failing companies on major exchanges will reverse split to hold a $1 share price...
You can find the initial listing requirements with a quick google (similar document). $4 is the bid price you have to hold, and in some circumstances you may be able to substitute a $2-3 close for the $4 bid. Bottom line is that the NASDAQ requires a $4 bid for initial listing. I believe that the NYSE is a $2-3 bid price for initial listing, depending on other factors.
Thanks for the technical analysis, I appreciate it!
So I've listened to the call too many times at this point. Nader says that they can announce the results of the IDMC analysis in 4-6 weeks. He then says they believe that they can release full combo data (all 50), in best case, in "around 8 weeks" from the date of the call. Listen around 16:45. That's based on, presumably, a faster rate of enrollment than they've actually experienced, but it's not 2 weeks after the last patient dosed + 6-8 weeks plus (hate to agree, but it's true...) the CYDY factor. It's more like the CYDY factor applies to enrollment, and then it should be a week plus a few weeks for analysis.
I know you're frustrated - I am too - and I know that the timelines I just laid out from the call aren't light years from what you were saying... but hopefully it makes you feel slightly better. I think all of the delay is on enrollment, and analysis should be a matter of weeks, for whatever that's worth.
Bucky, while I understand your general pessimism about the timelines we get from the company, etc., I'm not sure I follow your logic here. What's the 6-8 weeks (pre-CYDY factor) that you mention here?
I think the problem is that nobody with any clout, e.g. SEC, is actively watching the trading on the OTC. My read is that rather than looking backward at misconduct, this is a public service announcement that someone WILL be watching going forward, so conduct shenanigans at your own risk. I would imagine most MM would rather just go play somewhere else than risk shady dealings with a stock that has served them notice that someone is watching.
Not that I would rob a gas station, but if I were going to... I'd pick one without obvious cameras and security.
Agreed. After thinking about it for a minute, I'm very hopeful that this is a shot across the bow of the MM just prior to releasing more news that they think should move the stock. It would make sense, and maybe work to maximize the effect of a big PR even if it would be difficult or fruitless to prove historical manipulation.
One can dream...
Well... not the PR I was hoping for, but ra nice to see that they apparently care about the share price. Hopefully this isn't a waste of time and money.
Fair enough, I see the point. That said, PPCB's balance sheet is really bad. There are still plenty of good examples to use though. ONCX comes to mind... same basic situation as PPCB, but funding locked up through 2018 more or less and large institutional holdings from biotech players.
Either way, the point stands. Back to ENDV... I like the tweets, but we need some real PR's here. Hope to see that data from the heart trial very soon.
I actually follow Propanc. Australian oncology company just starting phase 1 trials for its lead drug candidate. They do have ODD, but definitely not an FDA approval. Very odd comp for ENDV. Currently trading right around $0.20, been volatile and falling over the last few months.
No idea why they'd use that as a comp, honestly.
Do you (or others) ascribe the recent drop in trading range to anything in particular? It was so steady around $0.20 for a while, and now it's 30% off of that level. Nothing seems to have changed... any insights? Thanks in advance.
The annual JP Morgan conference you're speaking of in SF is indeed invite-only for presenters.
Agreed, we were pretty happy to hear that. We were also incredibly pleased and surprised at how responsive Mr. Redman was to our questions. I think both are a good sign for our fortunes here in the medium- to long-term.
Actually, that's not quite correct. A colleague of mine emailed Redman earlier today with a direct question about the requirement for moving to the high dose group. We got a quick response stating that they would - assuming a good safety readout - be allowed to move to the higher dosage after the 28-day initial treatment and the 14-day safety review period. No need to wait the full 99 days.
We had the same concerns regarding timelines, and were quite pleased to hear that this was the case.
Still here, just nothing to say. Excited about the way things have moved in the last week or so, patiently waiting on additional news...
But that's not what you asserted. I know it's hard, but try to stay on topic... you said that you believed they were analyzing sub grouping in an effort to "keep the lights on". Would you care to support that one with facts? You should be well-prepared for this moment, since you've been making this claim for months.
Despite the fact that this has been impossible all along, since the company was always blinded to the data...
Hey look, that was a fact!
That's not all you're saying. You're saying that they're slicing and dicing the data to find some correlation to keep the lights on. That very clearly suggests that you're asserting that the data is weak, therefore the company is hunting and pecking for something positive. See post #19008, for anyone paying attention at home. This is the same tripe that you've been trotting out for months, even while the company was still enrolling the trial! Which, for all we know, they still are...
At least have the courage and decency to stand by your own baseless statements. Better yet, try supporting them with facts.
You've been guessing that for months now. All the while, the company has been blinded to the data (see last PR) making this an impossibility. Although we don't know for sure that the company is still blinded, your guess is just as baseless and asinine as it ever was.
It's typically not with referencing the clinical trials site for up to date information on things like enrollment. Companies are only required to update the info something like once a year, and most of them don't do any more than they're required on this front. Just FYI, appreciate you sharing regardless.
Even without holding warrants, I agree with you completely! The "time to corral funds" issue is why I was originally so sure that great news was absolutely imminent on the heels of the warrant offer announcement. At this point, I hope they extend the warrant offer a few weeks to allow for the data and the lead time for holders. I'd love to see the majority of the warrants convert on great news, fund the company for a little while without being dilutive!
I think the key is that the only way that anywhere near the total of 51mm warrants get exercised is if the share price is already elevated and going up on good news. For example, one holder here noted that the market price would have to be over a dollar before he would exercise at $0.50. Without good news that can truly sustain an elevated share price, I'd be very surprised to see more than a few million of the warrants with the highest "normal" conversion price actually convert. We won't see 51mm shares hit the market all of the sudden when it's trading at $0.56!
You seem to be missing the point a little bit, so let me try to explain... Those warrants have already been issued in conjunction with previous private placements to raise money for the company. They were given as add on's - essentially, for every two shares you purchased with cash, you were granted one warrant. In the event of a buyout, those warrants would be immediately converted and thus add to the fully diluted basis. Since most here expect a buyout within, say, a year (pearsby will likely blow a gasket at that assertion...), those warrants are true, dilutive shares already issued that the company has not yet been paid cash for. Since the company ostensibly needs cash to continue trials, most shareholders would like to see the warrants convert at $0.50 to fund the company in a manner that does not further dilute their ownership by issuing additional new shares and/or new warrants.
Of course, the warrant holders need great news to convince them to convert their warrants at this point, or else they'll just wait til the assumed buyout. The company has provided additional incentive by offering a price reduction to $0.50 for all warrants for a limited time, giving warrant holders an economic reason to put their cash on the table now instead of just waiting for the payout at the end. If some warrant holders convert and immediately sell, so be it. Doesn't help the share price now, but it is better economically for all shareholders in the event of an assumed buyout.
Does that help clear up the thought process?
Thanks Saltz, seems reasonable. Any thoughts on whether or not the company may decide to use a strong mono update before combo PE's?
It's interesting that you chose not to use my entire quote, purposefully admitting the preceding "on the surface."
In addition to trying to be consistent with your thoughts, please at least attempt to be complete with your quotes.
Pearsby, with all due respect, you recently provided me an example where the FDA approved a drug through Accelerated Approval after a P2 trial with an N=12. With questionable data, at that! And we already know that the FDA intends to review the results after 10 patients (last we heard, 9 were complete...) to determine if it was ethical to continue treating with placebo.
At least try to be consistent with your thoughts.
That's a great point trding, and dovetails nicely with a conversation that I was just having. I've been fairly critical of management's apparent handling of the warrant repricing offer with regard to the timing of combo data. It seems to me unlikely at this point that we'll see the combo data prior to 12/22, and I've always assumed that's the data that a warrant holder would need to see in order to convert. On the surface, looks to me like management may have bungled that one.
I'd never considered the possibility that a a mono update could or would be presented to combo results. I always thought that a mono update would be an add-on to combo results to help support a potential uplist, etc. However, as far as I know, the company could release interim data or observations on mono at any time since it's open label. This might actually be more within their control than the combo data, and could have been their fallback plan when announcing the warrant repricing - if you don't have combo data in time, you could always give a mono update.
Saltz, Lawman, other self-identified warrant holders... would a strong update on mono enrollment, efficacy, and safety be enough to make you think about converting? Honestly, I'm trying to think of ways that maybe management didn't botch the repricing window if they won't have combo data, and that's the best I can come up with. Interested in your thoughts.
That's very interesting. If true (and I'm not doubting you...) I would tend to agree with your assessment. Was this in a filing somewhere and I missed it?
Rather than relitigate this, I'll just provide a link to my previous post on this matter:
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=136785361
All very true, but you also have in place one of the most cautious and dovish Fed regimes in quite a while. They've clearly been gun shy from raising (still historically low) rates too quickly, and they have the balance sheet to manage inflationary pressures for quite some time. Not saying that a general recession couldn't occur due to standard business cycles, just that it appears to be a ways from overheating and I don't see the nuclear trigger present to tank the economy in short order.
I do agree that the equity market seems overvalued, but even a pretty healthy correction at this point would leave the market sky high by historical standards. A 10% pullback in the DJIA would still have it ~22,500! Whether that's a meaningful measure is another story, of course. And, as I've been fooled by this bull market before, I'm sticking with "the market can remain irrational longer than you can stay solvent"! I'm not even sure it's truly irrational at this point, although I was previously convinced that it was.
All in my opinion and in good fun of course, but I don't see our valuations between at severe risk from recession/business cycle in the next 6-12 months barring some trigger event - currency crises, tech bubbles, subprime mortgage markets, etc. That said, I'd prefer to get a deal done and not risk it!
I agree with this as well. There is one thing that gives me some comfort in this regard though - I don't see the structural catalyst for a major correction at this point. To me, likely candidates seem to be the auto market, student loan market, and crypto market. Auto isn't big enough to cause a 2008 style meltdown, in my opinion. I don't think crypto is tied in to the fabric of the economy enough to do anything more than localized damage when the music stops on those tulip bulbs. And student loans? The government is the major bag holder there... that can will get kicked. Of course, it's always what you don't see that gets you, but for example the subprime mortgage market was an issue to those paying attention as far back as 2005-2006. I just don't see that major trigger at this point, which makes me hope we have some time on this front.
Disclaimer: I'm not an economist, but I kind of play one on tv.
I agree with this nearly completely. And I hope you're right!
I haven't done an in-depth analysis, and others might be able to provide more clarity, but I believe the bulk of the warrants still have a little bit of time on them. There are some that are nearing expiration, I believe, but it's not the majority. My belief is that solid news is needed to entice warrant conversions, not just the time aspect. That said, I'm not a warrant holder.
I agree with your thought that the company thought that they would be able to release something more than they did re: interim results. Poor communication, poor management understanding... whatever the case, it doesn't make me feel great about management at the moment. Luckily it doesn't change the science at all, which is what we're all here for anyway.
I see, thanks for the insights Hyperbolic. The wait continues...
Thanks for sharing, Hyperbolic. Wish we were all privy to the same level of communication! And that's not a knock on you or anyone else invested through Paulson, of course.
Impressive. Most women, particularly middle-aged or older, can't come close to benching their body weight even once. If you haven't considered elite level Masters powerlifting, perhaps you should.
My perception of your credibility aside, you continue to misconstrue my point, intentionally or not. So I'll make it very, very plain. The FDA would gain virtually nothing by granting accelerated approval for PRO 140 at this point based on interim PE. They have to wait a matter of weeks for full PE, at which point it would be a much simpler decision politically. If they were to grant AA at this point, with the trial needing (at most) a handful of additional patients and PE observations at 1 week, they would be setting a precedent where any drug nearing the end of the clinical process might ask for AA instead of just finishing the trial. The point of AA is to save significant time, like the years saved in the examples you listed. In this case, they could grant AA after the full data set for PE comes in, and it's literally only weeks of difference. Saying that AA off interim data instead of complete PE data would save 6-12 months is at best missing the point - all I'm saying is that if the FDA were to grant AA (which they might, who knows!) they would wait for the full data set at this point. Again, that's for PE only, not the secondary outcomes, not the safety data... all that would be required to continue as confirmatory studies. Just like in the examples that you listed. They'd still save, say, 5-11 months instead of 6-12 months, and they wouldn't set a terrible precedent. I actually think that this is a quite possible outcome if the PE does in fact show that it is effective, which I believe it will. At a minimum, it could serve as a "rescue drug" for those failing HAART while they get the safety data in place for full approval and broader labeling. Just my speculation there, of course.
If you still care to search for examples, which I'm not asking you to, the oncology sector is just fine. Just remember, I'm looking for examples where the FDA stopped a trial (or granted AA, etc) due to positive efficacy findings when they were 80% of the way through a P3 trial, and expected the full readouts on P3 PE's in a matter of weeks. Honestly, the fact that you're having to search that hard for the example answers my question about whether that was a common (or even uncommon!) practice for the FDA. It's quite clearly not.
This all DOES beg the question of "why an IDMC in the first place?" I have no idea, and I honestly assume that it's probably naivete and mismanagement by Pourhassan. If the company knew all along that they weren't themselves going to see unblinded data and be able to PR that, then I believe that the result they got from the IDMC was the best that they could realistically hope for, and that was pointless in my opinion. In this case, this was a cheap concession from the FDA for expanding to 50 patients because I think they knew that they'd just ask to continue the trial to completion. If the company knew that they weren't going to see/PR unblinded interim PE data, it was at best a terrible miscommunication to shareholders. I think everyone was under the impression that we were going to see that data, even if that's not exactly what was said on the call. Never said that any of that made me feel great about management.
What I'm saying is that the FDA has little incentive to end the trial - based on interim primary endpoint efficacy - when the primary endpoint with full data should be available in a matter of weeks. The FDA can easily, if it so desires, allow conditional or accelerated approval in a matter of weeks with a full data set for PE instead of interim. The additional 24-weeks is irrelevant to this point, and you know it. It can be kept as a confirmatory study, as a condition of approval. So the FDA gains almost nothing by stopping the trial for efficacy at this point. Your examples show nothing like this - one was a P2 trial with low N, but the P3 coming after it required 160 patients observed out to 96 weeks. That's getting the drug to market probably 3 years faster, minimum. The other was a 238 patient P3 that was roughly halfway enrolled and had a treatment period of 72 weeks. Again, at least 2 years faster, probably a good bit more when you consider enrollment speed. I'm left to believe that this is the best you can come up with, which supports my premise that the IDMC recommendation means nothing more than it's not definitely futile. I don't believe that there's any information there regarding whether or not the data is exceptionally good. On the other hand, I believe that the company has insight into the effectiveness based on knowing that patients have to start with a viral load over 400 copies/mL, and comparing that to blood work from early in the open label portion. The algebra there is quite easy. Thus, they initiated the warrant conversion effort. They (apparently) bungled the dates, but have very good insight that the data will be good.
Again, I never said that it hasn't happened, but while arguing it, you've failed to provide anything remotely similar to the situation that I'm proposing. It hasn't escaped me that nobody else has come to your defense here and provided scores of their own examples.
Still wondering how much you're benching these days.
Another bad example. That was a phase 2 trial, and the drug was granted accelerated approval (controversially, might I add), with the requirement of a confirmatory phase 3 trial. A quick look at that P3 protocol shows why... 160 patients, primary endpoint observations out to 48 weeks, secondary observations out to 96 weeks.
https://clinicaltrials.gov/ct2/show/NCT02255552?term=eteplirsen&rank=1
That's nothing like the situation I'm asking for: phase 3 studies, needing only a handful of additional patients, and primary endpoint observations in the very short term. I'm not saying it's never happened, or that I've done extensive research to try to FIND an instance of the FDA stopping such a trial for (positive) efficacy at that late stage in the game. But I am saying that you've taken two big swings and two big misses, which isn't helping your argument (that the interim analysis must not have shown convincing efficacy) one bit.
Will the third time be a charm? How much are you benching these days, by the way?