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Thanks tonyd57, I'll take your word on that for the time being. Haven't even looked at NYSE initial listing requirements.
BL,
Just as a point of clarification, CYDY would actually qualify for the second tier (Global Market), not the third (Capital Market). While all standards for Capital Market require some level of positive shareholder equity, the third option for Global Market (Market Value Standard) has no requirement for shareholder equity. For everyone's reference, the only requirements under that particular standard are:
- Market Value of Listed Securities: $75mm (CYDY currently is ~$120mm)
- Publicly Held Shares: 1.1mm (CYDY is well above that...)
- Market Value of Publicly Held Shares: $20mm (Haven't checked numbers, but I doubt CYDY is ~85% closely held...)
- Bid Price: $4 (We've discussed this at length elsewhere)
- Shareholders (round lot holders): 400 (Can't confirm, but I'm sure they meet this one)
- Market Makers: 4 (Haven't confirmed myself, but you can check L2 data)
Anyone see anything I'm missing here?
Good question. From the NASDAQ FAQ page, under the question "Can a seasoned issuer effect a reverse stock split to meet the minimum bid price requirement for initial listing?"
A seasoned issuer may complete a reverse stock split to comply with Nasdaq's minimum price requirement for initial listing. Generally, when this happens, Nasdaq will require that the issuer continue to meet the price requirement for a minimum of five consecutive trading days after the split takes place. This means that on each of the five days the issuer must at some point during normal trading hours have a price which is at or above the applicable initial listing criteria.
Please note that Nasdaq may, in its discretion, also require an issuer to maintain the required minimum price for a period in excess of five consecutive business days, but generally no more than ten consecutive business days, before determining that the issuer has demonstrated compliance. In determining whether to require a longer waiting period, Nasdaq will consider the following four factors:
Margin of compliance (the amount by which the price is above the minimum standard);
Trading volume (a lack of trading volume may indicate a lack of bona fide market interest in the security at the posted bid price);
Where applicable, the market maker montage (the number of market makers quoting at or above the minimum required bid and the size of their quotes); and,
The trend of the stock price (is it up or down?).
There is no assets requirement for the market value standard , which is the third column for Global Market on page 9. I don't see anything that would eliminate CYDY from that standard.
Hey Martygx,
That appears to be correct... for the top tier of the NASDAQ. There are three tiers, and I believe that CYDY would qualify for the second tier (Global Market) under the Market Value Standard. Check page 9 on the Initial Listing Requirements.
https://listingcenter.nasdaq.com/assets/initialguide.pdf
I think you may be right that some of the standards for Global Select Market were changed, but it appears to me that CYDY would still qualify for the second tier under that particular standard.
I'm certainly not a lawyer though, much less a Bored one, so there's certainly a chance that I may be misinterpreting these standards.
Looked to me like the options already issued, but I haven't read it closely. I'll check back later when I have a chance.
I like your thoughts, and hope they're correct! I'd love to see a deal with no need to go to a major exchange and draw this out, although I'll admit that I won't let myself believe that that's the most likely scenario.
I'm interested to hear more context about your experience with reverse splits, as I've never been through one. I have a few thoughts, and I'd like to hear how your (and others') experiences align or may differ:
I think the negative trading trend for most stocks after reverse splits can probably be attributed to two things... lack of positive prospects for the company in question, and investor sentiment around R/S. To the latter, I suspect that it functions much like technical analysis - which I'm not knocking or disrespecting here - in that it becomes a self-fulfilling prophecy at times. For example, if TA "sees" a double top, the most likely next move is down, correct? But since that's common knowledge, it hits a feedback loop where anyone using TA is selling because the common knowledge is that the price is going down, so technicians sell, which in turn puts downward pressure on the SP. Similarly, most investors have negative expectations of stocks post-R/S, so they tend to sell, which tends to fulfill the expectations of falling price.
To the former point from above, not all R/S are created equally. The vast majority are executed to either remain listed on a major exchange in the face of a faltering SP, or to take sub-penny stocks to a more reasonable trading level to try to generate interest and free up the share structure to raise more money. Neither of those cases are confidence inspiring, and certainly provide the rationale for the canned "R/S is bad, price will go down" response given the frequency of this situation for R/S. Makes perfect sense. But I've struggled to understand how a R/S would go poorly in this case, particularly if (hypothetically) there is positive news around GvHD and mono to back it up. Institutions are more sophisticated than individual investors, on average, and theoretically at least some would look past the immediate bias to see inherent value for what it is. Similarly, those with the ability (capital) to short a stock significantly should theoretically recognize the risk of shorting a stock with what appears to be significant positive prospects. There are so many easier, safer targets - see the next paragraph - that I'd presume most would rather play in another sandbox. Properly managed, I struggle to see how the major risk to the SP arises for CYDY... although the market has certainly baffled me before.
My last thought is a continuation of the last paragraph. I've done a reasonable amount of quick research into pre-revenue biotechs that R/S to uplist from the OTC to a major exchange... and sure enough, most of them fare poorly. To my surprise, when I dug deeper I realized that these companies seemed to uplist at random, and least when I attempted to correlate the timing of the uplist to big positive news for the company. Most of them are doing it with drugs in P1 or P2 it seems, and not even on the heels of positive news or with expected results in hand. Much less with primary endpoints on a pivotal P3 for a drug with a large potential market. This blows my mind, and all else equal appears to be imprudent management. I'm left to believe that the majority of these firms were struggling to fund themselves and uplisted out of desperation at inopportune times. It appears from my limited research that CytoDyn is in a different place than just about every OTC R/S-uplist story that I found in this regard.
None of this is to attempt to convince anyone of anything, more just to put my thoughts to paper and see if anyone has thoughts or experience. I'll go back to my first thought - I'd still love to see this go straight to a deal instead of the R/S and uplist pathway altogether!
This is the last I'll be responding to this conversation, because it's quickly becoming pointless.
First of all, the phase 3 trial for Ibalizumab was substantially dissimilar in that it was a single-arm open label trial as opposed to a randomized controlled double-blind trial. Similar endpoint measurements do not equate to similar trials, and also do not equate to wholly identical possible inferences of observed individual outcomes from statistical tests even with similar numbers of patients enrolled in the trial. I'm not saying that Ibalizumab isn't an effective drug or that their reported p value wasn't impressive or anything of the sort, just that this is not an apples to apples comparison when trying to impute the possible number of non-responders from trial to trial. Simply more intellectual dishonesty or lack of understanding.
Regarding the interpretation of the p value for the Pro 140 trial, I'll refer you here For more reading on the fragility of p values to non-responders in a randomized controlled trial:
https://www.sciencedirect.com/science/article/pii/S0895435613004666
I'll even do you a favor and quote the most relevant section:
Consider a hypothetical example in which two RCTs at low risk of bias evaluate investigational drugs compared with placebo for the prevention of myocardial infarction. In the first trial, 100 patients are randomized to receive drug A and 100 patients to receive placebo. Fewer patients who receive drug A suffer a myocardial infarction (one vs. nine patients, P = 0.02 by Fisher's exact test). The second trial randomizes 4,000 patients to receive drug B and 4,000 patients to receive placebo. Fewer patients who receive drug B suffer a myocardial infarction (200 vs. 250 patients, P = 0.02).
As both trials were at low risk of bias and their results demonstrated nearly the same P-value, one's confidence in a true effect might be similar. However, the results from the first trial would be easily influenced by a small change in the numbers of events. If only one more patient experienced a myocardial infarction in the treatment group of the first trial, the P-value would change to 0.06. Despite the still impressive relative risk reduction of 78%, it would no longer be considered statistically significant. In contrast, adding one event to the treatment group in the second trial would have no meaningful impact on either the P-value, which would remain 0.02, or the point estimate of the relative risk reduction, which would remain 20%.
Bold text is mine, and please note that the Pro 140 trial was roughly one quarter of the size of the hypothetical "small" trial in this (peer reviewed and journal published) article. This isn't a perfect analog to the Pro 140 trial either - but it's a damn sight closer statistically than the Ibalizumab trial. I'll leave you to draw your own conclusions since you seem to excel at that, and you may want to show that to your source who is intimately involved in drug testing as well. As an aside, I believe that your reference to non-responders in previous trials is likely actually a recollection of rebounders. While not ideal either, those are not the same thing. If you're recalling another trial, feel free to refresh my memory and I'll stand corrected.
Beyond this point, I would suggest that one's credibility has little to do with their own perception, and much to do with how others view them. Moving the goalposts significantly on multiple topics - saying "low" when you meant "high", saying "huge potential dilution" when you meant "I agree that counting all of the warrants as fully issued shares is a good idea", etc - and only shifting positions when twice publicly called to account, isn't a great method of building or maintaining credibility. Using false and/or misleading wording (re: p values) to protect the uneducated from themselves is also, at best, misguided altruism. I still believe that you misunderstand the statistics.
Last, your "point" about investor lawsuits from the most recent raise borders on insanity. I'm like a suburban white girl in Uggs with a pumpkin spice latte right now... I just can't even.
We can agree to disagree on certain points, such as the meaning or intent of the fundraising events/strategy, or the implications of the wording of a single PR. I'll even go so far as to agree that management worries me, and I lack faith in their abilities to generate the absolute maximum return on this company. However, too many of your claims are misleading or simply ridiculous.
You're welcome, and thank you.
Somewhere deep in the blackness of my soul, it's not inconceivable that I may harbor some as-of-yet undiscovered virtues or redeeming qualities. However, I can guarantee that patience for foolishness is not among them.
I appreciate the response, but your original comments weren't welcomed by many because they weren't grounded in facts or reality.
Regarding p value, your initial post said:
"The low "p" value also tells you that there may have actually been many non-responders."
That's factually incorrect. A low p value is indicative of more conclusive data against the null hypothesis. Simply put and all else aside, it is widely accepted statistical practice that a low p value is better than a high p value, and p<0.01 is a very small p value.
Your response said:
"It is good but I have seen better and combined with the lack of detail about the patients response leads me to conclude there may be more non-responders or low responders than many believe."
Reversing your position in your second post does your credibility no favors, and suggesting that you've "seen lower" doesn't either. I find Kate Upton more attractive than Jennifer Lawrence - that doesn't suggest that Jennifer Lawrence isn't objectively attractive. She's still attractive, and a p value of below 0.01 is still very, very low.
If you want to make a statistical argument about sample size, confidence intervals, p values, etc... be my guest. We can have fun. I'll give you a hint though... in small sample sizes, small numbers of non-responders have the potential to greatly impact the p value. That's one reason the stat nerds prefer larger sample sizes - they correct for random outcomes in individual observations much more efficiently. In this case (N=52), a significant number of non-responders would nearly guarantee a statistically insignificant (read: higher value and not good) p value. The very low observed p value suggests that there were very few non-responders. Again, you can choose to disagree with statistical practices, but I'll side with the numbers.
I also believe that the wording of PRs are very carefully chosen. That's why I choose to interpret the words that are said, and not dishonestly paraphrase to twist meaning. Similarly, the fact that they didn't mention a BLA doesn't imply that there "likely will be no BLA for combo." Omission of a direct statement in a quick PR intended to get the word out that primary endpoints were met on a trial doesn't imply a wholesale change of strategic direction for a firm that has consistently stated that a BLA for combo was a planned step. Well, it doesn't to me anyway. You can read whatever you want, but that doesn't mean that it makes sense.
Regarding money, Paulson investors have consistently put money into the company. It appears to me that management was strategically raising money in small amounts in an attempt to minimize dilution and impact on share price, and they were able to get money whenever they needed it. You may interpret that differently, and I'll agree to disagree. I still think your comment about lawyers is baffling. Even if they were led to believe that they would be getting good news... that's exactly what they got. Primary endpoints were met. When did primary endpoints become unimportant? When did meeting primary endpoints in a phase 3 clinical trial become bad news??
Also, you mention in your response that there is "huge potential dilution coming from the conversion of the warrants just ahead". This signals to me that you don't understand the finance aspect at all - or you just don't care. In a buyout - which I believe that every person here suspects is the only way this investment ends positively, although I could be wrong about that - outstanding warrants are automatically converted. That means that on a fully diluted basis, those warrants already count as shares, are already expected to impact investors ROI at buyout, and nobody keeping score at home would count warrant conversions as new dilution. In fact, if you weren't already including those in your full share count, you should reassess your investment thought process. I, personally, would welcome the cash conversion of every single outstanding warrant, as it would preclude the marginal need for additional new shares (and associated new warrants!) that actually dilute the count.
I used to believe that you made some good points on occasion, even when I disagreed. For example, we've previously had exchanges where you suggested that the time YOU would target to get in would be after the last big dilution, and you were willing to give up the potential of a much better return if said dilution wasn't necessary or highly impactful. I get that. It's a reasonable investment thesis, even if it doesn't align with my own. But I no longer believe that you're the slightest bit credible in anything you say.
Ahah, I don't have PM but I appreciate it and I enjoy your posts as well.
Good luck to you!
I hope so, it's certainly been on my radar for a bit for this time frame. I personally think GvHD can be a bigger deal than some here expect. Pearsby's SRPT example might not be far off base...
I was actually hoping you had heard something a little more concrete to firm up the time frame. Oh well, we'll hear something when we hear it. Good luck to you, and thanks for the replies.
I actually don't disagree that I don't love the wording of the PR, and the fact that they never mentioned a BLA was disheartening. I would have also loved for them to mention a conference call to discuss results. But let's replay the tape a little bit...
- First, low p-value indicates strong evidence against the null hypothesis. A very low p-value - typically cited as below 0.05 - is a good thing. The company stated that it was below 0.01. That's VERY good. Why do you think they included the p-value in the press release? It suggests that the data was very conclusive. Don't believe me? You don't have to: http://blog.minitab.com/blog/adventures-in-statistics-2/how-to-correctly-interpret-p-values
- The company didn't say it would "help them recruit for mono". They said they "look forward to completing enrollment in our ongoing monotherapy trial". Those two statements do not mean the same thing, and it's at best intellectually dishonest to suggest that they do.
- You've been saying for as long as I can recall that Paulson is surely tapped out, the company is on the brink of a financial crisis... well, they raised $10mm (I know not all of that goes to the company) on Friday. Granted, it was not on favorable terms given the previous close and 10-day average. But they got $10mm. Doesn't strike me that they have issues getting money if they need it, and it probably just got easier since they now have met primary endpoints in a pivotal P3 and at least partially validated the science. Your suggestion that these investors would be calling lawyers is baffling.
- On the topic of the money, I wasn't happy that they raised that much money at that price, but it was likely an insurance policy. They probably knew that they would be getting the results back, but didn't know conclusively which way they were going. Because it was a blinded trial. Better to have the money and not need it, although I would absolutely like to hear management explain this for themselves.
- You have no basis for saying that there won't be a BLA for combo. In fact, the company has stated in previous press releases (10/13, for example) and conference calls (10/19, for example) that this was the goal they were working towards for combo. Your inference based on a (disappointing, admittedly) omission of three letters from a PR is wild conjecture at best.
- 1.6mm shares were bought (and sold...) today. That's far more than the average volume this share has seen in it's recent run up, and the biggest day I can recall. Demand increased significantly, because meeting PE's partially de-risks the investment thesis. The only thing that this price action suggests is that 20mm shares were issued on Friday at a 33% discount to the previous close, and they came with warrants. That math is easy... folks sold the shares and didn't care too much about the price, and they keep the warrants.
And before you accuse me of "not viewing this dispassionately", perhaps you should dispassionately review the statements above.
This is going to be fun...
1) For months, you've ranted about how the drug wouldn't work, the lack of severe adverse effects would correlate to lack of efficacy, etc... try again.
2) N=10 is a joke, huh? Apparently the FDA disagrees... and so did you, in a previous post. I asked (not you, just the board) if anyone could remember an IDMC stopping a trial due to positive efficacy 80% of the way through a pivotal P3 trial. You (tried...) to respond, in order to show that they WOULD have stopped the trial if the results were that good. Well, you failed to provide anything approaching a good example for that particular point, but you DID provide a spectacular example of the FDA granting accelerated approval to a drug after stopping a trial early. A P2. With N=12.
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=136769883
Go bother another board.
Thanks for the reply, much appreciated.
Actually, the protocol is for a 60-person study, double-blind, PE measurements at 100 days post-treatment. Management stated on the October call that the FDA would convene an IDMC after 10 patients finished treatment in order to determine essentially if it was ethical to continue treating with placebo, or if they should make it a single-arm trial. At the time of the call, they had nine patients who were enrolled - I believe all had finished treatment - and they were continuing to enroll. As I noted, your time frame COULD be about right.
And I hope that it is!
Lawman,
I'm curious as to any insight that you may have into the timing of the GvHD trial and hopefully an upcoming related announcement. I can back into the numbers and see that we're well over 100 days since the October conference call, and I'm hopeful that they enrolled patient #10 quickly, all went well, and the IDMC has had a chance to review the first ten patients... but I have nothing solid to say that they quickly enrolled, etc. Care to share what makes you think we should be hearing within a week or two? Much appreciated.
I'm interested because I agree that a favorable readout there - i.e. it's unethical to continue treating with placebo - would be a beneficial thing.
Aside from that, I'll echo you and others. What a strange, surprising, and disappointing day.
**Edit: I see that the Bored Lawyer can speak for him or herself**
I'm certain that the Bored Lawyer means that the legal relationship has been severed in terms of ownership. There is most likely a manufacturing agreement in place, etc. But hypothetically, any potential buyer of NWBO wouldn't have to also buy Cognate for example. And as others have mentioned, the conflict of interests picture is much clearer.
I'm certain that Cognate will still be manufacturing for NWBO, and the relationship will continue in that manner.
That's completely false, can't be traded pre-market. Should've known that you'd immediately be back with your lies.
I think you're right... if there's no news. If we get significant news, then all bets are off.
I think there are good things coming here... but it's way too early to plan for Vegas. Let's get that second cohort dosed.
Oddly enough, some bourbon and Charlie Sheen on late night tv is how I ended up here in the first place.
To answer your question, yes, most of those who have been here for awhile are aware of that connection - and often wonder why the company doesn't play it up more! Thanks for posting that though, always nice to have a reminder of the realities for patients that make this a potential game changer.
Oh, and welcome. Mostly good folks here if you have any questions.
Actually, the SP has been in the .50's for the past several raises, or I'd consider agreeing with you here. There's been no evidence of the company pumping the SP for raises in the past, so I seriously doubt that's occurring now, regardless of how it definitely happens with some other tickers.
That's not to say that there's not a raise potentially coming our way - there almost certainly is, unless they manage a partnership for GvHD or the like in very short order. However, based on past activity, I think the SP is rising in spite of any upcoming fundraising... not because of it.
Well, there goes the 200dma...
Sorry to hear about the injury, that's definitely a bummer. Hope the PT goes well and you can steer clear of surgical options!
Definitely has been a long time, hopefully we're getting close.
Did you ever decide if you'd be in the area for IM Boulder this year? Think you said your brother might be racing.
Right? It's unbelievable to me that this is holding .54-.55 or so when they're selling shares at .50. I could do without the delays, but I can't ask for more on the SP action right now than to be holding. I certainly hope t keeps up until we get some combo news.
If you're actually just stopping in cold, what's actually going on is that management has stated in both a 10Q and an investor deck that they expected to be fully enrolled with the new FDA-required number of patients by the end of January. Few here, to my knowledge, expect an enrollment PR.
Nobody likes the delays, but to suggest that they sell the company for whatever they can get right this second is absolutely ludicrous. And I'm pretty sure you know that.
I don't disagree with you one bit. It would certainly be nice to see some buying from insiders... but while I place a lot of value on insiders buying on the open market, and it scares me if insiders are unloading shares... I take the lack of action either way with a good dose of salt.
Either way, we shall see. Good luck to you.
Beneficial ownership is easy enough to find through SEC reporting and 10Q's, etc. Individual net worths is a tougher nut to crack most likely. While you have a point re: the relative size of an individual's investment, I think most folks who have $1mm+ shares of the company (that covers a couple of insiders at least, if I recall) and who also have a direct responsibility for the success of the company are properly incented to make positive things happen. For example, Tony C now controls indirectly (through family trusts) or directly about 3.7mm shares. That translates to generational wealth if this thing sells for $10 or something. You've got to be pretty loaded to sneeze at any 8-figure potential returns!
Yes, that's correct.
I can obviously only speak for myself, not any consensus that may or may not exist...
I believe that the company has the prerogative to PR anything they want once the data has been unblinded and analyzed. The exception would be if they wanted to publish the study in a journal, then there are embargoes on discussing results. I don't think they plan to publish this study, as it would take way too long and they're trying to get a drug to BLA. As a result, I believe that they WILL release PE once the data has been unblinded and analyzed. If, by chance, they DON'T meet PE, they will be required to PR as it would be a material adverse event with regards to shareholders. I'm open to hearing from others, but I don't believe that there is anything stopping the firm from unblinding after 50 patients have been treated for one week, although it's reasonable to assume based on past actions that they may over enroll to cover potential drop outs, and it's also reasonable (in my opinion) to think that they will consult with the FDA again before unblinding. Too much is at stake to risk being out of lockstep with the FDA. They don't have to PR informal meetings or discussions with the FDA, and I'd be slightly surprised if they do in this case.
As far as timelines, it's really anyone's guess to some degree. I think that it's very reasonable to believe that they are at or close to 50 patients based on their statements in the 10Q and the updated investor presentation. I assume it will take ~4 weeks once data is locked and unblinded to provide an update on PE. I'd venture that we don't see anything earlier than the end of this month, and probably not later than the end of next month. Purely my read and interpretation.
I have to agree here that I don't see the point of the DSMB review if there was no intent to actually release interim data. I think the firm thought that the market would read more into the DSMB recommendation than it did, for the most part. My group has confirmed with the company that they were always to remain blinded to the data (you can choose to believe them ex post facto or not...), and after re-listening to the call several times, they never stated that they would or could unblind the interim data. Just that the FDA had granted permission for a review by the DSMB. I, for one, heard what I wanted to hear when I originally listened to the call, and that was my fault. I think many here did the same. Regardless, the company delivered what was promised on that front. One can certainly argue about the value of the exercise though.
Also, with regard to full PE, Nader made clear that 8 weeks was a best case scenario. Tony was less guarded with his words on this matter as well, and I think they both should have been more conservative. Either way, I think that's good indication that they don't intend to run all patients the full 25 weeks before evaluating PE, as some have suggested. I'm hopeful that we'll see PE before the end of the month.
Again, I truly do understand your frustrations with the delays. I'm right there with you, and the opportunity cost of investing based on their stated timelines has cost me a lot of money. Just trying to keep the facts straight on promises and deliveries from the company!
I'm not sure which part of my comment you're replying to... I was simply stating that we had, in fact, already received the interim data promised on the October call, it just wasn't what we wanted. Buckysherm was suggesting that we were still waiting on that PR.
Actually, if you listen to the call, Nader promised results from the DSMB review of interim data in 4-6 weeks. And we got it pretty close to that time frame. Tony was a little less careful with his words, ironically, and many of us believed we'd see more actual data or analysis than we did... but we got exactly what Nader promised. We just wanted more.
I understand your frustration - believe me, I really do - but do keep the facts straight on the board.
No, it's an annoying tactic. That said, lots of folks actually check the breakout boards, so maybe we get some new action here. Come for the pump action, stay for the solid company...
This is the convertible notes from 2017 being converted to shares, with the exception of a $300k cash pay down to one holder. The notes matured today.
It does appear that some additional warrants may have sweetened the deal a bit, although I need to give it all a closer read.
Diamondjim,
I can't find a way to blow that up to a legible size. I assume by the lack of dancing in the streets that you're showing that the abstracts for tomorrow's publication do not include a publication from NWBO? Thanks in advance.
In my opinion, that is the key. The journal article has been submitted and is awaiting/in process of publication.
For what it's worth, here's my read. Disclosure: I'm long here, but not for nearly as long as most of you. As a result, I don't have the frustrations that many of you, very understandably, suffer from at this point.
I believe the blinded data on OS is going to be used to ask for AA. Although I haven't found a case where this exact scenario has occurred, it's right in line with what Gottlieb has advocated for at the FDA - using early views on clinical endpoints (instead of surrogates) for the AA pathway. The article below has been discussed before, but it bears repeating at this juncture.
https://www.reuters.com/article/us-fda-hearing-testimony/fda-aims-to-approve-more-drugs-based-on-early-clinical-data-idUSKBN1DU2DS
In my opinion, peer-reviewed and journal-published data, even blinded, that strongly suggests significant improvements in clinical benefit would be nearly bulletproof for AA under this guidance. That's why the trial hasn't been locked and unblinded - IT IS NOW IT'S OWN CONFIRMATORY TRIAL. They won't unblind it this spring, and maybe not next spring... but they won't need to if all goes correctly. And that doesn't bother me one bit, because I think we'll all be very happy by then.
As for not giving updates, this becomes self-explanatory in my mind. They made it clear today (according to reports here) that they're not allowed to give any information on the journal article prior to publication. The last real update they gave was 9/1/2017, I believe. The journal article was submitted in the fall of 2017. Occam's Razor says that's not a coincidence. If the hopes of the company in terms of applying for AA rest with the journal publication, you simply don't jeopardize that by talking about any updates that may interrupt publication. What shareholders want short-term - more public information, in this case - isn't always best long-term, as painful as that can be in the moment.
I don't know when the journal will be published, but I suspect it will be soon. I believe that's why they pushed the ASM back as far as they did - hoping that it would be published by now. They won't ask for the share increase until the journal is published, because the "no" votes from shareholders would be a given. Most will be happy to oblige under better circumstances, which, given that management knows the content of the journal article, they know will be coming soon.
Also, keep in mind that AA can happen very, very quickly. A quick scan of FDA AA's for 2017 (through 6/30) showed that no drug approved under AA in 2017 to that date took more than 6 months from BLA for approval. One - Bavencio - took less than a month.
It would have been great to get more concrete news today, but objectively, there's nothing negative here. In fact, I'm quite happy that the journal article was submitted months ago. That means our expected wait is mostly over. I agree that the SP may slip in the short-term, but I think that getting out now would be a poor choice unless you're flipping for lunch money.
I was under the impression that it has been common knowledge since July that the publication would be on blinded data. I'm quite hopeful that they intend to use the blinded data for AA, but it would be great to hear that from the company.
That's big indeed. Timeline for publication has been largely out of the hands of the company since the fall. No real surprise, honestly, but nice to have that confirmation.
Rogers, thanks for the information. I certainly look forward to additional color on what you're hearing today.