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Ordinarily, I'd be tempted to agree. But this presumes some sort of 'everything else being the same' context. And nothing has been stable in pharma over the past seventeen months: The economy, the M&A, the layoffs--everything has been in flux. And continues to be.
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The contributors to this Board probably watch Cortex more closely than anyone outside of Cortex employees. There has not been any substantive reason for the price to move up strongly--the financing extended lifespan, and staunched the bleeding. But the task remains the same: They have to produce a tangible achievement:
It will probably be a RD deal, with or without SA ( I have no idea which--so long as it doesn't include CX-1739)
Much less likely: ADHD/CX-1739 or neurodegeneration/high-impact deal
OR--positive SA data: And I am not counting on that after all this time, given the evidence that the apnea endpoint fluctuates a lot even without any intervention
It will require one of these markers of progress, not just a longer runway, for significant change in valuation.
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OT: Silenor
The most recent FDA communique was slightly more encouraging than I expected, but then again, I expected nothing positive. I don't know anyone who thinks Silenor has much potential, and the FDA has clearly disliked the program for years. This 'Insomnia Memo' was in NI January:
<<The Insomnia Memo:
Dear Pharma Friends;
Many of you have long considered insomnia to be an underserved area, and a target of rich potential for new sleep agents. We at the FDA have been thinking it over, and we have decided that we do not see it that way. We are OK with Ambien, CR and otherwise, and Lunesta, and Sonata/zaleplon. All of them are generic, or will be soon, and choosing from among them, most insomnia patients are adequately covered. For those who are not, there's that drug that was being hawked by the beaver and Abe Lincoln, the one whose name sounded like a monster from a Japanese horror movie: Rizerack, Roozerbub, Razorslug....whatever. Anyways, if you've been following the process, you may have noticed that new insomnia drugs have not had an easy regulatory path in the past few years. Indiplon (it would have helped if the right dose had been tested in the right patients); Silenor (doxepin by any other name, or dose, is still....doxepin); Intermezzo (Ambien CR under the tongue instead of down the hatch....yawn). We're just not that into them. Any of them.
So for those of you who cannot take a hint, here's the gist of the memo: If you come up with something really interesting, give us a call. But for the redundant stuff that is not going to be competitive against all those generics, forget it. Unless...unless you hire he-who-must-not-be-named, the guy who talked us into approving Fanapt. He's smooth, real smooth. He could talk us into approving heroin for Seasonal Affective Disorder. Hire him, and you've got a chance. Now you know.
Warm regards,
Your FDA>>
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OT:ALXA
I personally don't see a large home-use market. My projections have been based on psych beds, CMHCs, ERs.
I am not attributing much if any value to the migraine program. Alexza needs to find new payloads/indications, and there are lots of compounds which are not suitable for this inhalant system.
Tom King did a good job with Anesta, and now with Alexza. Biovail will be a solid, aggressive partner for this product.
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OT: ALXA: I'm very familiar with it--in fact I picked this program for a Nov 2009 Windhover partnering conference, and I believe it was at that conference that Biovail and Alexza started the partnering process in earnest.
This is what I wrote in a Feb 2009 sidebar entitled 'Wrestling with Agitation:Alexza's Alternative':
"While the cognitive and negative symptoms of schizophrenia are now a major chronic care issue, the positive symptoms often return as the acute-care focus when patients, due to medication noncompliance and/or the fluctuating intensity of their illness, become agitated, with danger to self or others. Alexza's AZ-004/loxapine inhalant delivery system has shown efficacy in Phase III testing, for both schizophrenic and bipolar agitation, and the NDA should be filed in early 2010. It offers an alternative to IM or oral antipsychotic administration (oral medications tend to be too slow, and patients often noncompliant) for agitated patients, which may seem a small issue to outside observers, but is not. During NI's early psychiatric hospital experience/training, this writer participated 800-1000 times in the physical immobilization of psychotic, agitated patients, often so that they could be given IM medications. It was and is a primitive process, three or four staff members tackling the patient; hopefully avoiding being punched, kicked, or bitten; while rolling him/her onto their stomach so that the IM injection can be administered. Even the IM route lags in its effect for 20-40 minutes, during which time the patient often must remain physically restrained, because recipients of a forcible injection in the buttock tend to not perceive this as compassionate medical care. This involves the risk of injury to all who are involved, and the risk of legal action against the hospital and ordering psychiatrist. The age of HIV also introduced the spectre of needle-stick HIV-transmission during this physical tumult. Forcible IM also establishes a climate of coercion and control which is traumatizing, both for the patient being medicated, and for other patients who witness the process. At times, the agitation which required physical restraint then spreads amongst other patients, as if it were contagious. This would be avoided with an inhalant alternative, compliance would undoubtedly be far higher, and its onset of effect much faster. AZ-004 produces a very rapid onset of effect (cMax in two minutes), the trials used 10 minutes as the first timepoint, wherein AZ-004 produced significant relief of agitation. An inhalant antipsychotic is also an intervention that can be offered earlier in the escalation cycle than IM meds, 'nipping it in the bud' before it approaches a dangerous crescendo.
The question is not whether this is a potentially useful tool for dealing with acutely psychotic, agitated patients; it is. The question is whether the American inpatient psychiatry system, which has been gutted by managed care, still exists in large enough scale to provide an adequate market for the product. We were initially skeptical, but the fact is that the highly agitated, psychotic patients who are the key market for AZ-004 are still those most likely to be seen in an ER or inpatient setting. Community mental health centers, which have taken up much of the treatment slack left by the decimation of inpatient alternatives, lack the staffing necessary to provide IM meds, and often have to respond to patient agitation by calling the police, a highly inefficient and clinically counterproductive option.
From a commercial perspective, the shrinkage of the inpatient psychiatric world means that marketing AZ-004 to psych units and emergency rooms would be manageable for a small sales force. In the January issue we suggested that exercising Alexza's increasingly expensive option to regain AZ-004 (and AZ-002) from development partner Symphony Allegro might not be worth the cost. However, in looking more carefully at AZ-004, we believe that conclusion was premature. There will be some pricepoint sensitivity if AZ-004 is $25 per dose, with IM haloperidol at 3.50--though IM Geodon is priced at $35 per dose. But there are also hidden costs to IM med use in terms of staff time, both for the medication administration itself and the incident reports that have to be completed for each involuntary restraint/medication. It is possible that this could become, due to speed and ease of use, a standard of acute care in hospital and mental health center settings, beyond the scope of simply replacing the extreme measure of IM drug administration."
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Officially? Periodic reports on potential subjects that enrolled, went through screening, and were excluded due to Factors a, b,c....Number of patients who met criteria of first two sleep sessions to go into third, with the drug/placebo testing. I don't think that they officially receive actual blinded data on each patient. But at some pre-specified points of the trial a DSMB must review the blinded data just to make sure there isn't some safety signal--does the apnea rate increase for some patients? Are there cardio indices that worsen during the third session? Etc. If safety signals were seen, the DSMB could suspend enrollment. It does not seem any of those things have occurred.
Is there a futility analysis built into the DSMB function--I don't know, in this case. They are usually seen in Phase IIb/III trials, sometimes small companies will issue a PR when a futility analysis does not tell them that nothing is happening (which can just mean that there is too much noise and variability to know whether something is happening or not).
Unofficially? Not that anyone would ever admit to this, but I cannot imagine that Cortex's Pierre Tran would not be occasionally asking the PI--have you seen any changes from Session II to Session III? The answer could be--we have seen decreases of X% or more in 2/3 of the patients tested thus far--but we don't know which ones were drug, which placebo--and because we also saw variability of up to Y% between sessions I and II even in patients we considered to have met the apnea standard for going to the actual drug testing--it could be partly or entirely 'noise' in the system.
(Imaginary conversation) Tran (pointing a small object in the general direction of the PI): But what do you think? Have you seen something that looks like a signal, like a trend towards a decrease in apnea rate? Quintiles PI: Don't tase me bro.....I do think there's something going on there....
This is purely speculation on my part. But Cortex has been extremely persistent on this, in spite of all of the enrollment/screening obstacles. These are not stupid people, there's got to be a reason.
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Medivation still claims to believe that they can file on the basis of this about-to-complete trial plus the Russian results. Right.
The $225 million in upfront money is less impressive when you consider that they have to cover 40% of the Phase III trial costs.
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I believe--though I might be misremembering--Pfizer is running three Phase IIIs of its own, using Dimebon with and without Aricept.
Pfizer's idea of Paradise=Showing the combination is optimal, then developing a combo Dimebon/Aricept, the combo being patentable. Hoping convenience might be a selling point, though payors tend not to prioritize convenience over price.
You are right about the current Phase III being started by Medivation before the partnership. It was just odd to hear it totally ignored by Pfizer. I have not gotten into the protocol details--I suspect the bigger difference would be the quality of sites used, though the trial durations are longer too, Medivation has cut corners there.
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OT: MDVN. FWIW,Here's a sidebar that may make it into NI March:
<<When will the first reasonable sample of AD clinical trial data for Dimebon be released? The European PI, Karolinska's Bengt Winblad, says it could be early in March. Pfizer and Medivation have both said it will be released by July. For Winblad, a very well-known figure in AD testing circles, to suggest that March is a viable timeframe, means that the data is nearly ready. It is hard to imagine Medivation and Pfizer delaying the unblinding, it is impossible to imagine them unblinding and then not disclosing the results. Not only are the data material overwhelmingly material for Medivation, the stakes around replacing Aricept are sufficiently high that it would also be material for Pfizer.
This may be the single most important data event of 2010. It is in the most valuable of potential CNS indications, for a drug whose chances of success are higher than any of the much-cited immunotherapies also in advanced testing (e.g. bapineuzumab). What will constitute success? NI's belief is that this trial will not replicate the across-the-board, stunning results achieved in the small Russian trial that has been cited more than it deserves. It will not produce a filing-worthy package in concert with that earlier trial. But Dimebon does not need to accomplish either of those goals to be successful. It needs to show statistically significant efficacy on its primary endpoint, optimally with benefit in a larger proportion of the patient population than the small plurality who do well--albeit temporarily--with Aricept. The side effect profile is most likely superior. It just has to be a little better than Aricept in terms of its impact on cognition. Even Dimebon's competitors are hoping for positive results, because failure would further squeeze an already paltry financing supply, while even unspectacular success will ease the funding path for other dementia programs. >>
What's also interesting is that when I saw Pfizer's CSO Martin McKay present the Pfizer pipeline last month, he did not even acknowledge the existence of this Medivation designed and run trial. He said Phase III results would be available in 2011, i.e. from the Pfizer designed program. Not exactly a vote of confidence in the just-completed-but-not-reported PhIII.
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Quintiles is a $3 billion per year business. They're not stupid or venal enough to work that way (I know their head of CNS trials slightly, I was on a panel he moderated, and will probably be doing another one in March). But, besides the ethical issues:
1) It's too easy to get caught. And successfully sued. Too many people would know the foot had been dragged.Which would then be a real deterrent for companies shopping for a CRO--do they hitch a ride with the scorpion?
2) It's not worth enough money to be worth the risk. If you look at the biggest CNS clinical trials, Quintiles gets most of those contracts--$50 million, $100 million.They don't need to steal.
3) There is however an unavoidable issue around boundaries: how to separate Quintiles the CRO with inside information from Quintiles the acquirer/investor. They can claim a firewall between the two, it'll be as porous as the firewall between investment banks and their analysts.
#3 outweighs my ambivalence, which is based on relief that someone out there wants to invest in pharma.
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I've refrained from commenting on this particular topic until now--because in general I prefer less censorship. But I think you've gone over the line on this--you're proselytizing, and it doesn't belong here. Whether or not it's "for (our) own good" or not, isn't your call to make.
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You may be right--but while they may have continued to put people into screening, adding to the roster of potential subjects, I still wonder whether Quintiles ran expensive sleep studies during a time that they weren't sure Cortex was going to be able to pay for them. Since they bear some, even most, of the responsibility of the disconnect between expected and actual enrollment timeframes, they should have cut Cortex a lot of slack.I'm just cynical about companies making ethical decisions like that.
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1) Cortex didnt have any money, and has not been in a position to increase the target n.
2) I believe they have had to screen a couple hundred people--even with loosened criteria--to get most of the way to their target of 20. I also suspect that their recent near-insolvency probably delayed running patients through the sleep studies themselves.
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No. That's not correct. There is a confusion of the number of people screened, as opposed to the number of completers. The goal is still 20 completing the full trial.
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I have no idea how quickly or dramatically the market will respond to OTC Cortex signing a deal of this size.
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First, note that the full quote is:
<<The deal will provide Cortex with cash to continue the business, and equally will leave us enough to continue with our own clinical development efforts.>>
Thus he is indicating it will provide funds for operating expenses, and to prepare for, probably initiate, the next clinical trial, which would be in ADHD. Not that it would be sufficient to fully fund both. I previously suggested $3-4 million upfront, I still think that's the likely range.
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Right--and you bring up an important point I'd skimmed over: I am pretty sure Cortex did not have the money to do the full preclinical tox testing necessary prior to doing the Phase I I'd described. So there is some time and money that will have to go into that preclinical testing. But since this would be designed as a one-shot product, not used in an ongoing fashion, they should not have to do the extended-duration, high dose testing necessary for the oral version.
As to your patent protection question--so far as I am aware, reformulations for the sake of a new delivery modality get the same twenty year protection, though that timeframe starts with the original filing back at the early stage of developing the drug, so the effective lifespan would start there for CX717IV (I havent looked to see when it was filed). Probably a 12-13 year functional patent life.
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They do have a RD package to partner: Oral CX-717 has an efficacy and safety package, which precludes chronic use. It could be used prophylactically, but it is interesting that Varney does not raise that concept in that article. More likely: There is an IV CX-717 which has been developed, but not tested in humans. The licensee would have to run a Phase I trial to show the dosing needed to achieve target (as established by the oral version) blood levels of CX-717--the same thing any new formulation of an existing drug has to do--and to show that there are no safety issues associated with the IV process--i.e. injection site issues or something unexpected from the different pk profile.
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There is probably a way to figure out the increased risk of surgery (the analgesia component still requires a chronic drug) in sleep apnea patients, who would be at an age and BMI where medical issues are more frequent. But I don't have the time to figure it out. This does point to a potential avenue for RD clinical development: Parse out a high risk population (e.g. sleep apnea patients undergoing general anesthesia with opioids, or even the Propofol light anesthesia used with some arthroscopies) so that you are not dealing with the very low base rate of RD in the general population undergoing such procedures. Somewhere buried in my notes was a set of incidence rates for RD in various populations: on the high end was home use of opioid pumps for severe pain, but I suspect major surgery in medically compromised patients would be up there. That might be how Cortex is positioning it for partnering.
Dew: The retinal detection of Alzheimer's. As you were pointing out, no one actually knows what pattern of retinally-detected degeneration is associated with Alzheimer's. Beyond that, that paper referred to it having been tested in animals, not yet in humans. Which means that they were basing it on transgenic rodents. And testing rodents which have had their brains crammed full of amyloid via a genetic tweak is already in doubt as a method for assessing anything in human AD, including drug effect. The idea that it is an accurate model for diagnosing AD in humans where the production of beta-amyloid is quite different, to me seems specious. At this point, they have a possible new method for identifying animals which are transgenically altered to grossly overexpress beta-amyloid. This is anything but established as a human diagnostic, and my guess is, it never will be.
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Item 1: Not going to happen.
Item 2: How much of the current stock price do you think is predicated upon positive results from the SA trial?
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They've already run trials going through the dose levels that were problematic for CX717. The FDA was not going to take a risk of looking lax on a drug that had a safety signal, artifact or not. Without a caution flag, it won't be an issue for CX-1739.
RD upfront: $3-4 million. They need $3-4 million plus 9 months operating expenses to do an ADHD trial, so it won't be enough to get it completed--since they then have to be able to analyze the data and, if positive, partner it.
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<<but am not at all sure that CX-1739 would gain approval for phase II trials>>
CX-1739 would have no problem getting approval for Phase II trials in ADHD. If there is regulatory pushback (and I do not see that being as likely as it has become with insomnia, for example)--it would be around Phase III requirements and NDA processing. Provided there is no 'safety signal', Phase II testing would be allowed.
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Exactly. There is no way forward on just $1.5 million without CX-1739.
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That may be--but I was stunned to hear Richard Clark (Merck CEO) say last week at JPM that they were now assessing which projects from the merged entity should be kept, which ones culled. What have they been doing for ten months? In other words, presence on the roster right now may not be predictive of presence in 6-12 months, or any other qualitative judgments made.
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Good summary. I can't figure out what happened to move that partner from "30-45 days" to late 1Q either. Internal political conflict, people upstairs raised an issue the BusDev people hadn't considered in the original timeframe, or they were distracted by a change in management, whatever.
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It has become clear to me in looking into this (and not via Cortex) that Samyang is not in this to play Street Games with Cortex. They think they can make money on Cortex without manipulation. Nor do they want to own Cortex outright, or its constituent pieces. The individual who represented Samyang in the transaction is someone who has a neuroscience investment perspective, not a get-rich-quick-fleece-'em perspective.
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If you knew the real story behind that particular poster, which you do not, and a couple of contributors to this thread do--you'd be ashamed of yourself.
Really--take a look at your last ten or so posts. What is your intention? What point are you seeking to make? On a day where, contrary to so many predictions, one can justifiably conclude that Cortex's management executed a financing agreement that was much better than might have been anticipated, such sourness seems odd.
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OT: I have considerable sympathy for these psychiatrists--who in a mental health clinic setting for lower income patients, probably see a kid like this for a 1/2 hr screening at the request of the social worker who has the case--and then can see them for 15 minute followups once per month. If someone in that position scans a case file that notes the presence of 'bipolar' in the family, it gives them something to hang a diagnosis on, and something that they can 'do.' Otherwise, you're stuck telling an unmotivated family (at least in the instance being addressed in that trial) they should work on a behavioral treatment plan with the social worker, when you know they won't bother, won't follow through.
There are psychiatrists who do abuse the system, who get lazy and hand out meds like candy, who milk the pharma system for everything they can get (speaking of which--I actually shared a couple cases with Biederman, long ago, when I was training at MGH..). But for the most part, they aren't. Most psychiatrists--and I've known a ton of them-- are trying to work around the limitations of the state of the art, and within what reimbursors will pay them to do, to accomplish something for patients. No clinician likes feeling helpless.
In my era of training, the idea of diagnosing a young child with bipolar, and medicating them accordingly, was anathema. But I don't know if that's right either--It is probably true that some subset of kids with various symptom presentations do have some type of prodromal bipolar illness--the trick is figuring out which ones, and whether psych meds do more harm than good at that age. I don't know the answer to that. Biederman thinks he does.
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In a vacuum, we've seen price suppression work. But IF Cortex is able to finish that partnership, that will supersede any such machinations.
Secondly--we have become so innured to the concept that everyone circling around Cortex is a speculator/manipulator that the possibility that someone has actually made an 'investment' seems vaguely naive or foreign. I don't know Samyang, but I am pretty familiar with one of their other positions, NeuralStem. A fetal-source stem cell company (NIH's Karl Johe) which has finally gotten permission to start implanting stem cells in ALS patients. Seems an unlikely choice for someone trying to find targets for manipulation.
It will be interesting to watch the share price over the next month or so--and particularly after any actual news from Cortex.
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If you think that the price in April will not be higher than today's close, then you're right. But I think it will be, and significantly. To be sure of that, they will have to close the partnership deal.
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I'm quite happy with this deal. Compared to the scenarios where a PIPE would be priced at 7 cents or something like that per share (and thus $1.5 million would have required issuing 21 million shares), this is so much more benign.
Conversion cannot occur for three months. So what might be expected at that point onward? Since Cortex was priced at 10 cents per share at a time that all known cash on hand estimates had them as insolvent and at risk of closing the doors, having $1.5 million on hand should in itself benefit the share price--particularly since, in contrast to the PIPE, Cortex now has the opportunity to attenuate the amount of eventual dilution.
If they do sign that elusive partnership, the share price effect will of course depend on the identity of the partner and the terms. But with some cash and a partner (SA is at best a wild card for the time being) Cortex's valuation should still be substantially better than it has been when it was in fiscal extremis.
On the back of my envelope, assuming conversion and exercising in mid April, this is what I get for shares issued and cash in, and the cost per share (plus whatever interest has to be paid at 6%):
30 cents per share:
Total shares out 8.4 million
Cash in: $2.35 million
Price per share paid by Samyang: 28 cents
50 cents per share:
Cash in: $2.16 million
Total shares out 3.9 million
Price per share paid by Samyang: 54 cents
Obviously, the projections change based on whatever the share price is in April--and Cortex will have to execute in order to make any upside scenarios eventuate. If there is no partnership, it becomes much more expensive, but still cheaper than any PIPE they could have had. Samyang gets the company if Cortex can't pay them the $1.5 million plus interest next January. If they can't do that by then, it won't matter.
There are others on this Board who are better with these kinds of calculations than am I, if there's an error, let me know. But based on the back of my envelope, Cortex did a much better job with raising money than any of us had anticipated.
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<<This line of research may account for why there is reduced interest in ampakines among BPs.>>
That is most assuredly untrue.
It's an interesting paper, brand new, and as such, has had zero effect on BP interest in anything--Ampakines or PDE4.
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What I was saying was that a repeated return to the well, as was suggested by several who are forecasting a self-serving dragging out of the 'inevitable', would entail a probable loss of control of the company. I don't see that as pertaining to a single bridge financing at this point.
The potential outcomes remain the same:
An onerous financing followed by a partnership.
OR, if the partner really is just playing with them:
An onerous financing followed by a sale of the company.
In the unlikely (but given the delay, increasingly worrisome)circumstance that they can't raise money--they'll have to go to an interested acquirer and tell them--OK, we give, independence is no longer in the cards. A couple months ago I posted a pr about a company that did that, and received a bridge loan from the acquirer to get them through the M&A processing period.
In response to the question--why would the acquirer do that, rather than just let them go under and try to pick up the pieces for cheap?--it's because if they do that, there are other sharks who are also circling, and they could lose out in the bloody scrum.
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There are things to worry about with Cortex; that reverse split scenario is not one of them. The delay in announcing a financing, now that is worrisome. Whether R&R is playing games, I have no idea. But this taking too long.
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Yes, he can get $1 million without losing control. Your scenario suggested that he would do this several times, going through all of the newly issued shares. Having just doubled the shares available, he can't issue them all without setting up the likely scenario that the entity buying them will have--or can obtain--majority control of the company.
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If that's the only rationale available, then I am not inclined to be concerned about this. If you don't blithely skip through that 'series of mini-financings' part, and think about that would actually involve, especially in terms of the number of shares that would be in someone else's hands--it becomes obvious this is a red herring. Even if you are going to predicate your argument on the presumption that only self-preservation drives Cortex management, you are presenting a scenario where they would lose control of the company--which would be foolhardy. It really is nonsense at this point.
Would it ever be considered if a partnership had generated some increased valuation for the company, so that one could achieve relisting via a reverse split? Maybe--but that's not a nearterm consideration.
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Before you start fantasizing white knights, be sure you know who you are waiting for:
(from NI July/August)<<February 13, 2009: "Tang Capital has engaged in discussions with the (Vanda Pharmaceuticals) Company and the Board with regards to the strategic direction of the Company. We believe that in order to maximize value for all stockholders, the Company must cease operations immediately, liquidate the Company’s assets and distribute all remaining capital to the Company’s stockholders." At the time that Mr. Tang demanded immediate liquidation, his 15% share was worth about $2.9 million. Of course, he did not get what he thought he wanted, and Tang Capital's ownership stake in Vanda had reached a value of $59 million at the end of May. It really is better to be lucky than to be good.>>
Just a little counterbalance to the grass-is-always-greener thinking that concludes that everybody else is smarter; if only we had so-and-so on our team.
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You have omitted IV CX-717, which has shown HOC/POC in preventing respiratory depression in acute use. Which means that it could be used either as a RD-preventative in surgical settings, or as an acute RD-reversal agent in the ER. What it cannot be used for is as a chronic preventative, like for patients receiving ongoing opioids for severe pain.
<<Then do a 10 to 1 or 20 to 1 reverse split, reducing the shares outstanding to roughly 7 to 15 millione>>
--you are not alone in suggesting this, several others have as well. But no one has yet explained what the point would be. The only rationale I can think of would be meeting the price-per-share requirement for listing, but I think they have other valuation issues that make that a moot point. It's not like they will have run out of issuable shares even if they do a financing along the terms you suggest.And as someone else noted, they'd need shareholder approval for a reverse split.
So you are positing a nightmare scenario based on....no rationale at all.
If there is a reason that they would pursue a reverse split, someone please explain it to me. Maybe I am missing something. Otherwise, this is nonsense.
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No. Given the clinical need, and the FDA's stated interest in a better option, I'm still surprised/disgusted that pharma didn't respond more positively. Anticipating that they'd be such cowards? Only the most hardened cynic could have predicted this. It's an embarrassment, and it's only become evident as time has passed. Big Pharma, with all of its resources, shies away from even reasonable risk--which this is. Instead they do things like ( Novartis, as an example) partnering iloperidone: How many 'atypical' antipsychotics is that now? Would it be possible to find a closer mimic to Geodon? Cephalon spends tens of millions to switch Provigil users to Nuvigil, whose only real advantage is a longer patent life. Redundancy is seen as less dangerous than trying to do something new, never mind that it offers little to patients. It's pathetic.
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It's doable, but as Gfp notes (and we have discussed this before);with no defined path to regulatory approval, pharmas become nervous, because they can't forecast the size, design, and costs of the testing necessary to take it through to commercialization. Which then complicates their 'sale' of the program to the rest of their company.
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