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Re: PR and acceptance.
Whooops! I thought you were saying approval, not acceptance!
I most gracefully appologize for a really stupid post in that case.
Re: When A owns shares...
First, sorry for mis-represnting your position, not intentional.
On dividends, this is simple. The borrow arrangement adjusts for it. My question on dividends was if A's dividend payment still recieves the tax break, as it is no longer really a dividend, just a payment in-leue of a dividend.
On the voting issue, try and make it real simple by assuming eveybody has paper certs. In that case A put his cert into a brokers hands, and he lent it to B who sells it to C. The share (and vote and dividend) is now with C.
Why should the company care the nature of how the share got where it is? They don't know or care why C now legally has it. You (A) could have sold it, lent it, willed it, or lost it in Vegas. C now has it, and that's the story.
There are not more paper certs than XYZ printed, just that A thinks he has one when in reality C has it.
A has no legal rights, period.
Voting on borrowed shares
I once had a nice link to paper (I forget if it was legal of scholar) on this one, but I lost it. I will try and find it when I have time.
But it goes like this:
Bio is correct that when A lends B a share to short, and C buys it, then C has the legal vote and A has no legal vote. Very simple at this point.
The problem is that there really is no "A" here, because most shares are held in street name. Thus, E-Trade may have 70K votes allowed, with 80K shares held by their clients. So E-Trade just mails out the proxy's and hopes for the expected result that less than 70K come back.
If more than 70K come back then anybody whos shares are in a margin account can lose a vote. It is really up to E-Trade to do this (but they can not take votes aways from cash accounts).
Naked short shares could in theory provide a real problem, but the amount is so small it jus doesn't matter.
It is always correct that if you have a share in your name, or a cash account, you have a vote. Any share you buy is a voting share, it's up to you to decide to place it in a margin account and lose vting rights.
Re: "I think BLA acceptance is a given since they have the the PR designation already."
Just to be clear, the PR designation has very little relationship to the chances of FDA approval.
I agree the chances are good (but who posted 99%??), but that is more based on EU approval and the fact that the goat milk version is almost the same as human antiT.
But I do agree with you that the price is now driven by the financial/partner/buyout side, for better or worse.
Biowatch, I am somewhat confused by your post.
I was obviously joking, but your link to my post wrt rights allocations to the excess shares means I'm confused?
I certainly stand by my point on how voting works.
On dividend taxation, the Bush dividend law certainly never addressed this issue, and I am not aware if the IRS/courts have ever taken a final position. This matters nill to me so it's not a case of beng confused, just a minor point that I don't care about.
But more importantly, both those items apply to longs with positions in a margin account, not shorts.
Re: Washington Mutual
Just a case of a short (the US$) getting there just reward.
There is absolutely nothing wrong in the world that a ban on short selling won't fix.
Program Survival Bias for Dummies:
JC has a contract with McD's to provide McChich nuggets. The contract calls for the company to weigh the McChichs on McD's provided scales (with some known margin of error), and only accept those over 10g. Furthermore, the same weighing will be used to provide the gross weight for billing (McD pays by the gram).
After a few months McD notices that the weight they measure upon random sampling of deliveries is tending to be less than that stamped on the box. What's up?
It's really simple. Some McChicks that truely are over 10g were not accepted, while some that were under 10g were mistakenly accepted. Both of these cause a BIAS of the final product weight.
This is all simple stats, hard to argue with it.
Clinical trials?
Exactly the same. There will definitely be a tendancy for P3s to have a HR less than than the P2s even if all the data is pristine.
One can argue to hell and back about how significant the effect is, but to deny it makes no sence.
[IMHO, seams kind of OT here as few doubt the efficiacy aspect of Proellex]
Re: fed insurance on money market accounts
"Anyone wonder that with the government today establishing Government Insurance for money market accounts if this could spell the end to savings accounts?"
Gosh, savings accounts still exis?
[OK, I know there is probably a substantial sum in them, but it just seams so old school]
Re: OT politics
But you really should read the energy policy Carter put in place after the Arab oil emabargo.
Drill and mine to the max.
Conservation
Funds for development of alternative energy
Nuclear
Limit oil imports to previous year levels
All removed by Reagan in the name of free markets.
Nowadays, no politicians can think past their next election.
Re: banks going toast and selling stock.
Well, call me crazy but when a company like Lehman needs to raise cash to stay solvent by selling stock then I seriously quastion WTF is going on. Only fools would buy in.
There was nothing in their core biz that caused the meltdown (unlike airlines and oil). So when the shit hits the fan you really have to wonder what all is up (or down as the case may be).
I guess what S&P said was that they ran out of greater fools in the Lehman story.
And were shorts selling AIG over the weekend?
There are plenty of scum on Wall Street, and they work both sides of the aisle. Just like in DC.
Re: is it true? [that shorts are breaking the system]
Yes, a heavy player can drive a price, and it works both ways. Remember the Hunts' silver play back in the 70's?
But that is not the case here (in our financial institution crises), unless somebody is playing games on the value of the crap debt.
None of these companies rely on stock sales to raise capital. The problem is the balance sheet. None of the mentioned companies could have raised cash through a stock offer.
The only factor that short selling has in these cases is that it speeds the collapse of the PPS, and perhapse makes it harder for people to bail.
Small biotechs are very differnt. In that case the company often relies on the stock price to raise fund.
Do not equate RPRX(for example) and C here. Whatever the true value of RPRX is, the PPS is being driven by shorts betting on the financing. Citygroup is falling because nobody really wants to own it and their SIVs until the credit crises plays out.
Re: is it true?
This obviously has nothing to do with anything other than the Nov elections.
Lehman bankrupt.
Merril Lynch sells before it goes toast
AIG bailed out for $80Billion
Washington Mutual sucking wind
Wells Fargo..
SIV's crashing, how is City?
Bear Stearns bailed out by the taxpayer
And the problem is shorts.
Right.
Re: AIG
If the deal is really that good for the US, why didn't AIG just go chapter 11, sell off some assets over a couple years and re-emerge? There was no indication they had had an operating cash issue (other than of course the need to pay off the loans that wuld have been due this week).
The obvious speculation is that even selling off the many valuable assets doesn't get them out of the hole.
Put it this way, it is quite likely that in the Ch 11 scenerio they would end up cuting a deal on some debt, and the shareholders would get zip da do nothing.
The truth may very well be that the deal was structured this way in order to give hope for the common.
[All very speculative when we know neither the bailout terms nor the financial situation]
Re: BPUR, Oxy, justification?
You claim Dr Natanson owns 50% of the patent in question.
Last I checked, he was listed as one on the inventors, which has no relationship to the patent holder.
So we have one of 2 scenerios:
A) He seriously lied about not knowing of the patent.
B) He was just a meaningless co-inventor and your statement is wrong.
I actually care little either way on bio-pure, just curious if you can back your claim he has 50% ownership.
Re: The holiday patent.
Actually, I never thought the patent would provide any protection against other SPRMs using a drug holiday, I always considered it just an attempt at a time extension for Proellex. The prov. app. will not determin the claims (it can list claims, but they are not that significant). As it is harder to get broader claims past the examiner, it is quite possible they will be narrowed down in scope.
If they really did get a patent issued that claimed the holiday concept for any SPRM, then I agree with you.
I never did realise provisional patent applications are not published.
Re: Patent protection against other SPRM's.
Of course this patent can't do that.
The purpose of the patent is to enhance the IP rights on Proellex.
It's the way patents work, if you think you have something of value you keep submitting more "add-on" patents.
IMHO, quite bogus. But it is SOP.
Re: Xrymd and ZGEN's PPS
I have already posted a half dozen death threats under various aliases on IV and Y!.
Seriously, this market is so helter skelter right now, shit happens. I would buy in for more except it's likely to drop again tomorrow.
Not a patent lawyer thank god, but I did have to review patent issues in my previous job (telecom, not biotech).
First, don't assume anything is non-obvious. Can we just mention the Amazon 1-click patent? [Cookies, already in existance, were created for just this type application. All Bezos did was add "shopping checkout" to the state of the art]
But on the issue of defending the patent, hptaxis really misses the boat. Nobody will issue a challange until Pro. is a success (and after the NIH patent has expired). After that, it is trivially easy for RPRX to milk it out for a few years even if that can't defend it.
Also, htaxis goes on ad-nausium about the details of the NIH license agreement. Gee, is this the only in-licensed drug in the world?
Certianly I do consider this a weak patent, but that's not significant enough to stop me from buying in, ONCE they raise their cash.
BTW, how timely for you to arrive on the board hptaxis, just before a financing.
Re: BIOD, "Which of the two trials"?
The Type 2 trial had the 95% interval at -0.4 to -0.1 delta between arms, given that they later say -0.6 missed the inferiority margin I assume negative numbers are not good news.
Re: Y3Max's prediction on Canada
Last time we tried that we failed miserably.
Re: BIOD's insulin variant
It's not quite fair to say that it was only stat sig by excluding India, as that was the Type I trial only (and type II is obviously the "market").
OTOH, I suspect the real issue is that it was stat sig inferior to Humulin, despite being stat sig non-inferior (yes, I think I said that right). How common is that?
It's probably not a good idea to have an also ran in this market.
Some early halt info.
From the FDA: http://www.fda.gov/cber/gdlns/clintrialdmc.pdf
"Such boundaries can serve as useful guidelines to the DMC in making recommendations regarding continued accrual to and conduct of the trial. The DMC will usually recommend termination when these thresholds are crossed, but it is not obligated to do so, since other aspects of the interim data may complicate the issue. For example, the data on effectiveness may be very strong, with a stopping boundary having been crossed, but emerging safety concerns may make the benefit-to-risk assessment non-definitive at that interim review. FDA expects the sponsor to direct the DMC to exercise its own judgment in such circumstances; the DMC can be flexible in assessing the data relative to the stopping boundaries. If the DMC recommends early termination for efficacy before a boundary is crossed, however, and this recommendation is implemented, the Type I error cannot be preserved and the study results may be difficult to interpret."
I.E., the DSMB can recommend to halt the trial early in such a case, but the FDA will seriously question the data. "difficult to interpret" is not good, particularly in a P3.
Let's try an easier argument. If the DSMB should stop at p=.02, then that is what the SPA should say.
Re: T-DM1
Yes, this is definitely IMGN's linker technology. More significantly it is clearly their lead candidate as of now.
A descision by DNA to go forward with P3s for T-DM1 will be a serious boost to IMGN's PPS.
Re: blaim Joe for the financing situation.
I have to modestly disagree with you corp.
The game of "whack the biotech" has been going on for years now. When you get down under 6 months cash, your head pops up and the hammer comes down.
I'm not really being anti-management here. As far as I see, they are doing a good job of pushing the drug along (and I blaim the FDA for the Androxol issue).
But they clearly miss the point that the price per share will drop until financing, "de-risking" be dammed. Unless they have an wild card tucked up their sleave, it's a case of better early than late.
Every time I have made a bad entry point decision in a biotech, it was directly because of a subsequent financing that took a 30% or so hair-cut.
I have nothing bad at all to say about RPRX, but I will NOT buy until after they get some cash.
RE: country based generic rates
So what are China and India at?
I mean REALLY at, not what the label says.
Re: ZGEN
The Atacicept deal is fairly obviously about cash. Seams like it saves them enough cash to last out a 2 year ramp up of RecoThrombin. And despite some naysayers, I still believe the RecoT is a lock (some people just have NO patients).
So they trade [(50% US profits) - (15% US royalties) ] * risk against up to $300m of costs savings over the next few years. Seams OK when you consider it enhances the pipeline value (as significant dilution is far less likely)
On a related issue, they also dissolved the joint preclinical R&D projects they had with Merk Soreno, and split the pipeline. Perhaps just tiding up loose ends in case of an offer?
RE: INGN
Both the BLA and MAA were filed on the last day of Q2.
Anybody care to bet there were executive bonuses tied to that?
PS: I think using INGN amd cynical in the same context is an oxymoron.
Re DNDN and capital
I am out and just watching, so maybe I am wrong. But I thought DNDN had already established sufficient credit facities to get through the 9902B final + 9 months?
ZGEN just anounced a CC out of the blue,
(at least as far as I know), for Set 3. Seams like some AH buyers think it could be good news
Re: Androxal is dead
I'll stick to my theory on the trial. They have had some partnership discussion(s) that imply this data could help the with partnering andro.
I have no clue what the reg. path is to support my claim, just that it makes biz. sence.
And our new found mystery poster is very unlikely to get any respect w/o some clue where he is comming from.
Did CTIC just set a new world record?
Just like in Bejing, the records just keep falling.
http://biz.yahoo.com/prnews/080825/aqm051b.html?.v=1
That makes it 16.5 months between reverse splits!
Congrats Bianco and crowd
Re: ENCY
And how much debt did Encite have?
The intangible asset value on the books will be
Price paid + debt - real assets.
It has 0 to do with assigning a true value, it is just a book balancing concept.
P11 question
Does anybody know if there is another interim analysis, and when it might be?
io, you got your math backwards on the 10%
With enough rats and the right criterion you could have 10% chance of a false failure, and .00000000000001% chance of a false pass. The 10% does not imply there is a 10% possibility the drug is carcinigenic.
Of course, your latter point about the number of rats seams very valid.
Clark, any coments as to why a company couldn't just increase the N on these trials?
Hopefully the sponsor doesn't need to get signed consent forms
Re: EMEA Yea vs. FDA Nea IDEV's Nebido
It's been on the market for a few years in the EU and got axed by the FDA for a rare alergic coughing side effect.
I don't see how they are saving cash with the P3 early termination because they need a large safety database regardless of how the P3 efficicy data plays out. Hardley matters if they collect the safety data from follow-ups of the P2 or something else.
Perhaps the real driver for this that a partner wants to see Pro. started in a P3 trial before inking a deal?
Where the hell is Doc
Re silicon v silicone
I have no real problem with the dude not realizing the correct pronounciation. You hear something wrong all the time, you might have such an issue.
Hey, I was the arCtic poster from a while back
But not knowing that they are different materials does qualify as a blooper.
Re: recombinant plamts?
In the last CC I heard this. Real or just fluff?
Just looking for a cheaper way to feed the goats?
re: DNDN's HR
Are you saying that DNDN powered the trial based on a constant HR of 1.45??
Did you get the I/R girl drunk or something to tell you this?
Re: "DNDN: Don't shoot the messenger..."
No problem with you, I am just truly stunned that he could have said the interim change REDUCED the chance for interim success.
Clearly assigning more alpha will INCREASE the chance of interim success.
It's fine if he wants to maintain his position that Provenge does not work and the only thing 9901 saw was an inbalance, but on the interim change hurting he is off the deep end.