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Agree with that completely.
Also, the FDA defines an unmet medical need as "a condition whose treatment or diagnosis is not addressed adequately by available therapy." There is a whole subsequent laundry list of FDA-defined situations where an unmet medical need may exist where there is already an existing therapy available. So it seems that the FDA may be in the business of more than just statistical analysis, no? I'd provide the link, but it's easy enough to google, and I doubt you'd read it anyway since it contradicts your statements.
After all, you're the one who said N=50 was allowed due to an unmet medical need.
ICPT is a terrible example in the context of the discussion, which I clearly framed as asking for examples where the DMC stopped for efficacy when only a handful of additional patients needed to be enrolled, PE is after 1 week, etc. ICPT was stopped with about half of a 238-patient trial enrolled, and the treatment period was 72 weeks. Would you care to try again?
Also, to say that you've remained objective on the topic of efficacy is a farce. You've repeatedly stated your expectations regarding efficacy, particularly for monotherapy. Despite it being an ongoing trial...
I feel like the second half of that was responding to me, so I'll follow up...
I never said "low N due to unmet disease state equaled a successful trial". I asked you how your concession that it was an unmet medical need meshed with your ongoing assertion that there isn't a need in the market for a differentiated treatment since HIV patients are doing so well on HAART? It seems like the FDA disagrees with your position.
I'm also still waiting for examples of any instance of a DMC stopping a trial due to great efficacy when the full data set on a recently renegotiated protocol was expected to be available in a matter of weeks, maybe a month or two.
I'll wait.
It's shocking to hear you concede that the low N is due to an unmet disease state. Care to elaborate on how that statement jives with your general opinion, stated ad nauseam, that HIV patients are doing just fine on HAART and you don't seem to see the space or need in the market for a differentiated treatment option?
Not to mention, is the DMC really going to recommend stopping a trial when they need to enroll a handful more patients (at most) and treat them for a week to see PE's? I'll plead ignorance on the matter, but I'd love to see an example where this actually occurred. It makes plenty of sense in something like a cancer trial that could go on for years, depriving patients of treatment. No DMC would say "you've cured cancer... now just enroll 200 more patients and run 2 years of data on each...", but allowing the trial to run at this point is (likely) a matter of a month or two to get to PE. I can't believe they would stop the trial, with recently renegotiated protocol, this close to the end of the trial. Doesn't make sense, I would never expect it in this case.
Also, to those (not you misiu!) claiming that the interim PE data wasn't good enough to PR or some derivative of this opinion... I'll refer you to the PR itself. It clearly states that the company remained and remains blinded to trial data. While I think that most of us assumed otherwise after the conference call in October, the fact is that the company hasn't seen that data, so the argument that it wasn't good enough to PR is nonsensical.
The fact that we have no news, while annoying, literally means none of that. In particular:
- They are not required to PR full enrollment, and may choose not to at this point. They may be enrolling patients still... or they may not. We have no idea.
- PE pushed into Q1 (at the least!)... see above. It's almost ludicrous to insinuate that it would push into Q2 at this point. Didn't you previously suggest that they could enroll at 4 patients per month, maybe 5 with the relaxed standards? That would mean you'd expect that they would enroll 10 by December 12 (two months from FDA meeting), or roughly Christmas at the slower pace of 4 per month. Hard to see how that goes beyond Q1 for results even in a worst case scenario.
- "Desperate repricing of options would have been a waste..." First, I don't see it as desperate at all, I think it's a brilliant move if you have/expect great data. Would you rather them release great data and immediately raise funds through issuing additional shares and warrants? I wouldn't. I'd rather them provide incentive for current warrant holders to convert, thus not increasing shares on a fully diluted basis. I agree that it appears, outside looking in, that the timing was mishandled, but the company does reserve the right to extend the deadline at their sole discretion. I don't think that would look great for management, but it wouldn't make it a waste (or even a bad move) if it generated the intended cash.
- Another round of Paulson dilution... see above.
Not to say that I like any of this. I'm annoyed by the fact that we haven't seen interim data, and have expressed my displeasure regarding the overall handling of the warrant repricing vis a vis trial results.
I do, however, agree that meeting their own stated timelines would be nice. They chose to put timelines out there - even if they were hopeful/soft, as misiu rightfully suggested - therefore they should do their best to meet those timelines. If they weren't sure they could meet them, they should have been more vague or omitted timelines entirely. If they're trying to live down past mistakes regarding optimism, they're off to a slow start.
Thanks for speaking up. I actually agree that it likely won't be effective for all patients. That would be unrealistic given the results from past trials, even assuming the company will adjust dosage this go round. As others have pointed out, 100% efficacy isn't needed for approval, so the devil will be in the details. Personally, I find it hard to believe that the FDA wouldn't grant consideration even if efficacy is slightly below the bar for PE, granted that the safety profile remains and there are still no observed occurrences of resistance to a CCR5 inhibitor-style treatment or to HAART. That would, in my mind, still make it the logical first choice for newly diagnosed cases, and you can move on to HAART if it doesn't work for you. Conditional approval with a requirement for ongoing P3/4 studies seems reasonable. All just my opinion of course, but it would seem in line with recent FDA stances regarding accelerating the approval process for drugs intended to treat severe or life threatening conditions.
All the same, appreciate your input. Hope we hear something soon on combo, then we can get to mono!
I'm not accidentally or purposefully taking anything out of context. Both of my posts have clearly said "efficacy to FDA standards." If that isn't being read as "effective to the degree that the FDA would consider monotherapy usage as a specific indication for PRO 140..." then let me put that to bed now. That's exactly what I mean, and I believe you're the only long here who does not think that the mono trial has a good chance of approval (assuming funds to complete, etc etc).
I'm eager to be proven wrong by all of those longs out there who agree with you, so I'll continue waiting.
I am waiting, patiently...
For the hordes of silent longs here who agree with your unsupported premise that mono has no chance of showing efficacy by FDA standards.
I'll just keep waiting.
I agree that there are many people on the board who never post. I follow a few boards in that fashion myself.
Now I'd like to invite all of these loyal longs, who always read but never post, who don't believe that mono has any chance to show efficacy by FDA standards... please go ahead and post now and let me know you're here.
A call for transparency is fine... but I don't know if you'll find many other "loyal shareholders" who don't believe that mono will be evaluated for efficacy, or agree with you that it can't replace a HAART cocktail for some, if not many, CCR5-only patients.
In fact, I can't think of anyone else ever suggesting or agreeing with that on this board.
That's certainly true. I'd hate to see them need to do that due to lack of data though - that would be a very bad look for management. And, at least in my circles, I've been one of the most lenient in allowing management the benefit of the doubt for a fluid strategy and lack of PR's. I'm very optimistic and positive here, but I also really don't want to see things continue to drag at this point without a little more clarity.
Either way, we shall see. I'll probably be up at 4am to check my phone, whether I want to be or not!
No problem at all!
Misiu, I'm talking about the 12/22 date for the end of the warrant conversion window. They need data to convince warrant holders to convert in that time frame, and they announced that time frame nearly five weeks after the conference call, so they had a good idea of where they would be with data at that point. Not arguing with you, just clarifying that we're talking about different things!
Generally agree with you misiu, but the company did put the 12/22 date on themselves, and it is very important to get data out in advance of that. Still, you're right that patience is key!
Agreed. I also have a theory that the company going over 30 originally and even altering the criteria some (you may recall the dust up over criteria being quietly changed to allow patients who had previously used Maraviroc) may be related to the denied ODD application and behind the scenes conversations with the FDA. Complete speculation on my part, for sure, and it still may not preclude your thoughts about over-enrolling past 50. Seems like that may be reasonable and prudent, given the importance of this trial and the outcomes.
All I know is that data can't come soon enough! I'm not sure how much longer I can keep waking up at 4am, like a kid on Christmas, to see if this is the day they drop the news.
Perhaps, perhaps not. Perhaps "two class resistance with limited treatment options" made up almost none of the original 40, and the population consisted mainly of resistance to three classes. You may recall that that this was actually the primary requirement for the combo trial (see clinicaltrials.gov), with two class/limited options as the second listed acceptable profile. If that's the case, the drop to two classes (sans limited treatment options) may open up a much larger population for them. I personally have my reasons for suspecting that it does exactly this, which should ease the burden of enrollment greatly. Also, I imagine the company kept records of patients it screened who did not meet the requirements, meaning that they may already have a roster of patients to contact who meet the reduced requirements.
I'm certainly familiar with the fact that they've been overly optimistic on timelines in the past, but they spoke with confidence on the conference call about enrolling quickly, and then put their money where their mouth is with the warrant repricing window. It would be disastrous not to release data - very preferably top line data on the full 50 - prior to the closing of the warrant repricing window. Keep in mind that they didn't PR the warrant repricing until roughly five weeks after that conference call. In other words, plenty of time for them to know how enrollment was going and to plan that window to capture results. I'll be quite surprised if it enrolls (enrolled?) at the same slow rate as the first 40 patients.
I share your surprise that we don't have data yet, and share your reasoning that the warrant repricing window indicated that we would have (good) data very, very soon. Maybe I'm ever the optimist, but perhaps they decided to skip the interim data review and release in lieu of data on the full 50, which they state that they expected to have 6-8 weeks from the conference call. It may be wishful thinking, but I don't share pearsby's opinion on enrolling the last 10 patients as a huge challenge comparable to the first 40. Time will tell, I suppose. With regard to your question to buckysherm re: Jody's statement, if the company knew they would be able to enroll the last 10 very quickly, they may not waste the time and money to pay a contractor to prepare interim data. Complete speculation, of course.
I'm hoping for a PR before the bell. I'm willing to give the company some leeway, as in my opinion they have to be given the leeway to be somewhat fluid in strategy right now, but I'll be very concerned if we get too close to 12/22 with no data. That despite sharing your belief that it's hard to see how the data would be bad.
Agreed. The original poster (who showed up today - coincidence, I'm sure) suggested such an avalanche. Regarding the future, obviously the belief of those who are long here is that the substantial capital raises will come at substantially better share prices based on news believed to be coming. That's the name of the game with pre-revenue biotechs, after all.
Warrants aside, I maintain that the conversion of debt would be net beneficial to company cash flow - reducing a current liability (interest due) has the same impact as increasing a current asset (cash). I really don't care whether someone gives me $10 or takes $10 off of my credit card bill...
That may be true - I'd have to double check the filings to see if there are any that don't. I've conceded that I missed the cashless provisions before.
Regardless, strike price is $0.09. Need to see quite a bit of SP appreciation from current levels before you see cashless conversions generating massive amounts of shares to be "dumped" into the market, as was suggested by the poster to whom I was originally responding.
And here, I'll concur that at least some of the warrants DO have cashless provisions.
**Edit - lost in that whole exchange was that the strike on the warrants is $0.09...
True... if there's a cashless exercise provision in the SEC filing.
Actually, that's not how a cashless exercise works. It works by immediately selling some of the shares at market price to pay for all of the shares you're exercising at your warrant strike price. So the company gets all money due for the warrants exercised, and the holder only keeps the portion of shares not needed to pay for the exercise.
Play again any time.
Correct on one point, so allow me to fix my sloppy language.
They wouldn't receive cash from conversion of debt to shares, but they would save the quarterly interest payment (which I'm sure you have memorized...) I'd draw up the impact to company cash flow, but I doubt you care.
It also seems that you don't understand what a cashless exercise is, but suffice it to say that the "cashless" part refers to the exerciser, not the issuer.
Sure, show me 43 million shares being dumped into the market...
Had you bothered to read the filing, you'd see that it relates to shares from existing convertible notes and warrants that previously would have been restricted from resale. So:
1) ONCX wouldn't get proceeds from resale, but they'd get the cash proceeds from conversion/exercise.
2) The shares don't have to be sold, they just CAN. Upon exercise/conversion. Which would only happen if the share price appreciated.
In short... try again.
I agree, that's been my assumption all along.
I agree that a ticker change, in and of itself, is somewhat meaningless. I think there are a few folks out there who try to trade ticker changes, but that's sort of neither here nor there in the long run.
Real excitement, at least on my part, comes from the belief that the company has stored up positive news to release once they're advertising for their own brand, so to speak. If I were running the company, I wouldn't PR anything pre-ticker change if I could help it, because I would want the association to be with ONCX instead of AEPP. This idea is supported by things Redman has stated in emails and that the company has had in presentations, etc. **edit: I also agree with microcap that several processes are likely to follow, such as adding another independent director and attempting to uplist to QB**
Right? Wrong? Meaningful? We'll see... but for me, the positive expectations are based on news that I presume will follow the ticker change. Not the ticker change itself.
My thoughts exactly...
With the limited time discount on the warrants, they'll want to give holders as much data as possible to incentivize that decision. I think we'll get interim data and combo enrollment tomorrow, which leaves time for full combo data before 12/22.
I think there will be a good explanation for that one when interim data is released and it will all make sense and they'll look perfectly competent. The interim data was within their control, but other things aren't/weren't.
That said, I generally agree with you that not many of these companies seem to exceed deadlines!
Why we didn't get results this morning. The explanation can be read between the lines of previous posts and the after hours PR today. I expect we'll get news on interim results tomorrow.
I get it now...
Ouch... I think you'll get your bone though, and soon. I actually put my money where my mouth is and bought more today. Although I'm surprised that we didn't get news this morning, I can't read Friday's PR as anything but a heads up that very solid news is coming very soon, so I took today as a gift from the company to purchase a few more shares pre-news.
Countdown to 6am EST, take two...
No comment on litigation possibility, because I don't have any clue in that realm.
In terms of impact to existing shareholders... best case is that with great news, lots of warrants convert and give the company operating cash. These shares count towards a fully diluted number for a buyout scenario anyway since they would convert at a buyout event, so it would be less dilutive than issuing new shares to raise cash right after positive news. It would also probably help the SP keep momentum, since many have assumed that any positive news would be immediately followed by a large raise. Of course, some warrant holders may convert then turn around and sell into the SP appreciation, but the hope would be that positive news would generate the appetite to absorb that volume anyway.
Seems to me like a very smart move if you know you're about to release strong positive news and you know you'll need some cash going forward.
Agreed, they certainly have a day or two of leeway on that front. I guess if I'm giving them the benefit of the doubt, you could say that NOT releasing interim data today - and instead releasing it after hours today, or tomorrow AM - would give traders who have followed the stock and can read the tea leaves from Friday's PR one more day to get in at these levels. Sort of throwing investors a bone.
Still, I clearly assumed that a PR this morning was most likely.
I'll be the first to admit that I'm not impressed. I'll allow a few days though before I get concerned.
I'm not a warrant holder, so my logic is hypothetical, but...
The only way it makes sense for warrant holders, particularly those who have significant time to expiry, to exercise their warrants at this point is if they are convinced that the share price will be anywhere near (i.e. as low as) their exercise price again. Otherwise, they'd be putting real dollars at risk unnecessarily, since they could always wait and see what happens and not risk their dollars in the meantime. Anything less, and there's no sense in putting your cash on the table for the company, even if you get a solid economic cushion from having your strike go from 1.35 to .50. Even if you're very sure that the warrants are going to be worth more in the future than they are now (e.g. the company releases very strong data...), there's still not much sense in putting your money at risk in the meantime in case something goes wrong.
However, this limited time offer for discounted conversion gives warrant holders a real economic reason to exercise now - you can put up about 1/2 to 1/3 the amount of money you otherwise would. This increases your ROI very substantially, and reduces the amount of real risk you take by converting prior to (anticipated) buyout. STILL, most with time left on their warrants would not exercise and take on additional risk without incontrovertible evidence that things are heading the very right direction, thus pretty much ensuring that the ROI they'll be juicing will be positive to begin with. It's just the only way that this move makes any sense whatsoever.
I'm not in the business of prognostication and I'm certainly no insider, but I'll all but guarantee that we have positive news on Monday.
Oh, and Saltz, this was really just an add on to your post. Not really directed to you.
I'll amend my statement slightly to say that it could be viewed as slightly dilutive if one assumes a timeline for buyout that extends beyond warrant expiry dates, and also assumes that management wouldn't extend the warrants.