Fair summary, nam, but I don't think our patents would protect against anything but T in (substantially) the SAME AI design as Vibex. I really think it's analogous to GM patenting a Cadillac. Ford cannot produce anything that looks, feels and acts JUST LIKE a Cadillac, but a Continental is fine, albeit it uses the same gas, seat materials, tires, etc..
We can't patent the entire AI concept, or even the subset that delivers SQ-HV. There's still a risk that one of the AI devices pointed to by loko (or another we don't yet know about), gets by the FDA long enough before the QST PDUFA, that it's just a matter of a P3 with T in it, as with Medac's bolus AI + MTX. Or else that that AI garners a great rep in the EU, so that, again, the FDA allows just a P3 with T in it, to qualify for a US PDUFA.
How big a risk? I dunno, but I think we need to keep an eye on the ball, and not just assume. Refutations welcome, I'd rather make money from my ATRS investment one day than see the same thing happen again.
nammuang: formally, I would think the answer must be "no", yet I've wondered that same thing. In Europe they used a completely different device (Metoject?). I tappy'd myself to sleep often with the thought that they must then have to go through FDA registration and approval of the device, including its ability to deliver MTX, P1-P3. Instead, as we know, they used an approved BD device, and yawned through in a trice, with P3 only.
Maybe those 2 UK companies are not interested in the US market at all but, if they are, might they not enlist BD to help with FDA approval? With T being altogether more controversial than MTX, they would then presumably have to go through P1-P3? Or could they get away with P3 only a la Medac?
I am not claiming expertise in any of this stuff, and am ready to be schooled. I just don't think there's much point in heads-in-the-sand investing anymore, with our heroes.
Yep. There was no 8-K when he hired on at Antares (though there WAS a PR), nor did ACTC put out an 8-K when he hired on with them.
Advanced Cell and Antares almost seem to have co-conspired silence. Not a PR between them. Strange, no?
If no one's called Howarth, asked why, and posted the response here, by the time the W. coast gets up tomorrow, then I undertake to.
tdp: I must not be expressing myself at all clearly. I tried to argue - against false_nam - that Teva is far more apt to partner with / buy A than start afresh with one of the newcomers - for exactly the kind of reasons you flesh out so well.
But - jumping topics now, from a possible Teva buyout TO the safety of the QST trail to profits - I don't think we A-longs can rest so easy about the present apparent advantage of A's position.
loko's links showed 2 or 3 subcutaneous AIs with high viscosity capability. Agreed that, so far, none is FDA-approved, but private companies do not need to tell us when they have applied. Alternatively, if one of them should enlist, say, BD to help them with the FDA process, they still have 2-3 years to get that on. Given approval of that AI device, plunking some version of T into it would seem no more difficult than it was for medac Gmbh to get MTX approved for THEIR BD device. I do not know whether the Oxford and Cambridge devices have already been approved in Europe (probably have because the companies are already touting for viscous biologic fillers). If so, it's going to ease the path to FDA approval, no?
To sum up: A seems to be ahead on SQ AI HV (high-viscosity) devices, and already have T-testing with ITS well in-hand - but the competition is one EXISTING device away from FDA approval in having a viable competitor.
It's a race against the clock for A as I see it. Partnering (at LEAST) with a BD or Teva would seem a great strategic move as that would tend to head-off potential competition.
As I evidenced, the thinking is NOT _purely_ hopeful. Teva and A have several partnered projects, both in existence and projected. Yes, Teva could buy one of the OTHER AI technologies at which I am eternally grateful to loko for pointing - but they already have that much more connection with Antares, so the price would have to be right (ie. lower) to look elsewhere.
I agree that ATRS, even at a BO price of 3-4, remains expensive to an outsider. It would take an attitude adjustment (AA) on the part of the insiders to acquiesce to what they might still see as too LOW a price. We might just be seeing that AA in the events of this year. But they do seem to be an exceptionally spineless, uncommunicative and DIVIDED lot, so who really knows.
nam_plagiarist: it's not really "the latest disaster" per se, but that "Teva buyout" has long been on the cards, and that "disaster" was a victory for one team in that specific struggle. As you know, Wotton was the leader of "go it alone", and Apple (we guess/assume) the "Teva partnership guy". Now that Wotton and his affiliate in the "independent sales effort" policy are gone, and Apple's star is apparently in the ascendant, it makes investors revive the old buyout card.
It is obvious enough there would be value for Teva in bringing a great AI technology in house. The question is always "how much" and "what price". When ATRS was 5 and Teva looking at having to pay more, it didn't happen, but with A at 2 (if we're lucky after this sheet hits the fan) and Teva looking at a more realistic A board, then 3-4 could well happen, especially - as tdp said - after Antares demonstrates the value of QST.
For all I know, Teva deliberately stonewalls on ATRS partnership projects as a means of softening A up. With A now signalling a weakening in their own INDEPENDENT sales effort, or at any rate risking that perception, I predict another delweine-buyout post on SA this week, or soon.
td: thanks for laying out so clearly the "faction/policy" aspects of Leroux's departure. I did not say or mean "retaliation" by the sales force, merely that substantial face time with doctors may have been missed in the period immediately before/after - as salesmen were briefed on organizational/policy/method changes associated with leadership changes.
We'll see soon enough, as you say. But it's sure a fat coincidence if these 2 things (Leroux and sales dip) are really unconnected.
I also do not think we have spoken enough here, about the kind of company that would just leave investors / analysts struggling to understand these things without a word.
OK, you're right - it really could be a coincidence that the first week after Jooste scoots, the sales figures stink. Yes, docs write scripts, not salesmen. But would there not be a PROPORTION of cases, each week, where the salesman makes a visit to Dr X, and X is then motivated to write a script or 2 that very week? Didn't happen that week, and the figures were off maybe 20-25% from expected - not 100%, just THAT much. Sounds possible to me.
If the next week's figures come in looking like the previous week's SHOULD HAVE, ie. about 570, then it looks like there were "absences" in the 425 week, a la salty. If they come in as bad as last week's, or worse, then it's demoralized/absent sales force. If there's a deviation UP as severe as the deviation DOWN that we just saw, then it was indeed just "bad data" for one week.
Why don't we consider evidence, instead of insulting each other?
My guess is one of the salesmen told pharmatracker. The bombed-out sales figure we just got (for week ending Oct-10) is for the first full week of work after the meetings (or other notifications) the sales force must have received during the week ending Oct-03. Could it be that they partially reflect a demoralization effect or, as salty said, that some or all salesmen were recalled for a strategy meeting? My previous hypothesis was "statistical or data-collection error"), but I now think it's too coincidental that the first week after Jooste walked had this stinking result. Don't you?
I would sell and take the loss tomorrow morning, but am wondering hard about salty's speculations about Teva. I imagine it's always been "on the table" between the companies, but they just could not see eye to eye on a price. It'd be just like me to sell the lot at 1.90, and then, at last, what's left of ATRS management finally capitulates to Teva at 4.
Just mouthing off. This Jooste thing has me badly rattled. He would NOT crawl off to ACTC unless there was some big "policy" or "performance" disagreement. Same with Wotton, of course. And the only possible disagreement I see is re. buyout. Would Teva salesmen replace the Antares force in a buyout? Maybe that's the demoralization. More knowledgeable people - please advise...
Not following you, salty - who's the good short candidate, who might announce dilution, ACTC or ATRS?
It doesn't sound as if Antares and Jooste are all that pally anymore (WHY?), and it's another massive strike against Antares IR (among the little details) - but I don't see that it inherently makes dilution more imminent, or even more likely at all - UNLESS that last sales figure correlates with some major rupture in the Otrexup campaign.
Thanks, whogo. Your post nailed it home. He's gone. I'd Remove my other post (wondering), but others already answered...
I just cannot fathom the nastiness of this company, in which I am so heavily invested. They just removed his entry on the Management page - 1984 style, an unperson - and not even a terse announcement?
Well, this time there is not even the semblance of normality, with the simultaneous announcement of a replacement, as if it was all scripted, as with Wotton. Now I have to call Howarth (only 2nd time I've done that), if only to see what positive spin he can put on this.
One has to look past the thief-in-the-night departure, and see the implication for the Otrexup sales campaign. What does it say about that, with Jooste now in the same sin-bin as Wotton?
affirmed: Please forgive my possible naivete, but are we quite certain he has QUIT Antares? To go from being a Senior Vice President Global Sales and Marketing to a (mere) Chief Commercial Officer? Seems like a bit of a step-down, for someone whose career has apparently successful hitherto, albeit rejoining with PW (but also in the Antares sin-bin??)
Obviously, Antares did not announce the "loss", or his replacement. Advanced also did not announce/trumpet the hire. When Antares hired Jooste, there was a PR. No such for his replacement? Neither company had any 8-Ks about any of this, too low a level for such, I guess.
I am no student of ACTC's business but do they yet have a FT job for a Chief Commercial Officer? Like Directors serving on multiple boards, could he just have 2 jobs?
Why come here then? Ultimately you have to take the word of the creatures that post here. Or at least some of them?
It is believed that the good drroid78 gets to view Symphony or IMS data. It is further believed that same are a somewhat valid proxy for drug sales, though there are known problems and possible inaccuracies.
But then, I'm just another anonymous, meaningless voice on a YMB. Please feel free not to take my word. Hey, nobody else here does!
Had the same (duration) thought, as did nammuang (now that's disturbing) - but a moment's reflection surely refutes this.
If patients have been getting a mail-order supply for 120 days, instead of 90 days (or whatever it is that is tending to push average script value into the high 700s from low 500s), then would it not be 2-3 months until we STARTED to see the effects of refill orders not coming in quite as quickly? From Antares' point of view, the longer the duration of scripts, the more it's LIKE a deferred-revenue situation (ie. like a long-term-contract purchase in a business like Salesforce).
My hypothesis, about this sudden gulch down, is that some entire component in the numbers did not report timely this week, or a wholesale mistake was made in it.
brunoq: agreed - we have all surely worried about this since Rasuvo came into our lives.
But before loko's post, I was in the tappy world of "no other SQ AI w/viscous capability exists". As aintno reminded us, it doesn't mean any of the AIs in question have even started jumping through the FDA hoops, but - as you say - it won't be a big shock if it is happening, or will happen soon, or even if BD copies one of the designs, or develops similar, and a European company steps up and provides DIRECT competition.
I think we Longs need to monitor all these channels closely, and not live in an ideological world where such talk is "heresy against Antares" (the nammuang/aintno school of "thought").
nammuang: then what on EARTH was your point in quoting it, in the context of THIS thread? Can't wait to hear your reasoning.
jrdelane: lokodude put up a vunderpost on SA (a comment under the recent Chapman article), providing links to a considerable number of recently-developed auto-injectors, most with ability to deliver a viscous liquid subcutaneously.
Many of the companies are openly touting for applications for their product, eg in biologics. To my knowledge (which is admittedly all-too-limited), none of them is considering testosterone, and none has approached the FDA to initiate a P1-P3. However, it seems to me that such may occur, and might even be for T. As long as one or more of these companies is privately-held (a la Medac USA), and as long as they apply before the date FDA approves Antares' NDA (ie. within about the next 3 years), the same kind of "surprise" could happen, as did with Otrexup. It was to all that that I was referring.
Oh, you may not have realized (since you replied to nam) that he simply quoted an older post of mine. Please allow me to translate the broader meaning for you:
nam: you see what heinous heresies this villain doth utter! Why would you pay attention to ANYTHING he says?
After the most recent eruption, both on SA and here, of Mount lokosuvius (on the topic of the Antares patent filed in Mar-14, and approved in mid-September), some tried to brave the swirling clouds of pseudo-scientific vapor, and ask him for clarification on the role of ETOH in the T formulation - only to find that the posts themselves had been somehow consumed (ie. deleted) in the flow of molten loko.
I am not a chemist, and felt there was no viable alternative but to fall silent amidst a barrage of sycophantic posts, as full of pseudo-science as the originals, from the self-appointed board-leaders (you know who you are but, in case you don't: nam and aint - please take a bow).
So it was as pleasurable as it was INFORMATIVE, to read the posts of rph, in the thread "Understanding Injectable Testosterone", started by cache, who shows here, and elsewhere, a praiseworthy desire, and capacity, to get after the facts, and eschew all the drama and drivel.
Ok, loko, I'll bite. Two q's, that I think many others here must have for you. Please answer simply, minimum of drama, if at all possible, and do not delete your post. TIA.
. what's so special about putting a T salt in ETOH? Does the specialness relate to the resulting liquid, the performance of the AI - or WHAT?
. assuming there is something devastatingly better about T in ETOH, that other AIs and other T-formulations just cannot match - what on earth prevents other companies from using two 100% public-domain commodities in exactly the same way, in their own AIs??
Suppose I create a peanut-butter / shark-ejaculate sandwich, and everyone agrees it is DELICIOUS and NUTRITIOUS. I patent the sandwich, open a shop, and the world all tries to cram in and get my tasty treat. Then, someone realizes: sandwiches, shops, PNB, and even sharks are PUBLIC DOMAIN. And they open a shop too. What's the difference with our heroes and their Vibex-T-ETOH?