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Re: HEB
"Why would they change the indication?"
It was a joke.
Over years, everytime we have SARS, 911 and bio-terrorism, bird flue, whatever; we would hear how Ampligen may be the big thing for that market.
The only market HEB has is on Wall Street.
wrt HEB,
Can they refile the NDA with an ammended indication?
If this is the best strategy, how long would we expect to wiat for the next "big scare" story to base a filing on?
Isn't this really non-news?
Since the previous trial data had strong enough points to provoke genuine debate, certainly one would expect a single P3 going forward to be OK.
The only real news to come will be the financing.
zip, if a company is challanging the SPA interpretation...
The company has the ability to publish the SPA, but they almost never do.
The FDA can not disclose this, so we have a very one sided public debate in these situations (ENCY for example).
If ENCY or others expect to convince the public that these are problems with FDA "wiggle room", then just publish the SPA.
But they don't, because I suspect it is the company that is attempting to "wiggle".
RE: 1500 patient safety database
This is for the chronic indication, which will be at least 3 years out. Hopefully, the anemia indcation will be on the market in about 2 years and provide the head count for safety.
A serious (non-tinhat) question on Dr Hussain's statements.
Dr Husain said both at the meeting and in his letter (I'm paraphrasing here) "I don't see how a drug that doesn't slow progression can have a survival benifit".
The problem with this statement is that he effectively states "Provenge has no benifit wrt progression", and this statement is totally without basis.
It is quite true that the P3 trials did not "prove" (i.e., P<.05) the case that Prov. slowed progression, but it did trend.
Anybody at the meeting stating "Provenge slowed progression" would have been quickly rebuted.
Yet, Dr Hussain said the even more unreasonable "Provenge does not slow progression", and was never questioned.
I'v asked this question before with no response. So if i'm just being an anal idiot on this feel free to slam me
That SeekingAlpha and MotleyFool are often cited as sources is incredible.
Maybe the Yahoo! mesage board should be the basis of all research?
Really, I don't mind somebody linking to a SeekingAlpha post if they want to, but when news aggragaters put it on the same level as AP we have a problem.
And the Fool has become 24x7x360 hype, how many times will you see a link there to "how you could have made millions"...
RE: PR on latest FDA meeting
It certainly does not take the BOD to approve such a PR (actually, it is more likely the case that the BOD could NOT control the decision).
That aside, it would not be insane to wait till next year. Try and ride tha Jan effect.
I hope I don't get boiled in oil for disagreeing with you. BTW, human flesh should always be served a-tatar, never boiled
Re: 5 X market cap buyout
Not clear how to really valuate the deal, but POTP might qualify. The price did jump from under .05 to over .25 on the reverse buyout news.
OK, I know that this is just the semi-scam of buying a broken listed company because it's cheaper than getting a listing. We certainly don't expect this here.
RE: Safe sex card as biz value
I think this depends strongly on what you mean by a business value. To me, this means something that will generate real profits that make investment worthwhile. To others, it means a concept that looks good enough they can sell for a fortune (especially in the internet spcae).
In the specific case, I really would doubt they can make money on this. BUT if they get it up and running with any significant uptake they can easily be bought out by the "social network" crowd [whatever that really means], and for a very nice profit.
This is really touching on next year(s) hot button of safety on the net social scene.
Personnaly, I think it's complete BS.
I may be a fool, but never the greatest.
RE: I am getting a bad feeling about this
Actually I like this. It means that the pumper and momo crowd is gone (I mean this in general for stocks, not a slap about anybody who may have left ths board).
Relax and stay liquid.
Once there is no interest, you can buy at better values.
BTW, I agree that proellex is certainly more of a "real drug", but if Andro gets to market it will generate a larger market cap than todays.
RE: Is this true
"FDA has not approved any small company's first product in last 5 years."
A much better question for the biotech values board.
But I will submit IDIX which had Tyzeka for HVB approved a while back. I do not know if this was their "first" product (I would be certain Dew knows off the top of his head).
RE: Safe sex: Will this work?
Since in the real world it will/would be used as an altenrative to a condom, it will have a negative impact on STD prevention.
OT, your brain on data lookup.
When I wrote the last post, I had DewD in the subject. Upon reviewing, I changed in to DueD.
Well, obviously I knew that the name was Dew, not Due. But when I went into mental proof read mode only the English term, not his handle, would come up. I even remember clearly reviewing this in my mind, and at that point I was certain enough it was Due that I didn't check (why the hell would I even need to check?).
Obviously I have seen his handle a few thousand times, and it is clearly ingrained in my mind. The point of this is that is seams the brain (at least my brain) has some context mode that affects data access. Once in "proof read" mode, valid words would somehow mask out simmilar non words.
Can I post in binary?
DueD, MNTA (and any) shorts shares.
Often these shares are part of a more complex position involving options and/or debt. As such, the analysis might be much more involved than you state.
P.S., I do agree that someone with a true short position in MNTA would be on drugs not to cover some/all [or at least use the profits to hedge up]. This would be the same as any former DNDN long who failed to cash some out after the A/C meeting.
RE : and how expensive can it be to keep track...
I don't think it's a cost issue. If it is strongly believed that the treatment has no effect on events after T months, then continuing the analysis past then would only add confounding factors w/o providing theoretical benifit.
Additionally, the significance of other follow treatments will further add randomness, which I think must drive the power of the trial down.
This is OT, as we all (longs/supporters/chearleaders/whatever) believe that Provenge does provide an extended survival benifit.
RE: That seems like a big advantage ...
IWFAL (one of the resident stat experts) stated that the tail doesn't help the p value a real lot because there are so few patients let in the comparison arm.
This makes sence for log-rank, because once the treatment patients live longer than the placebo patients it doesn't matter at all how much longer they go. Only the order of events matter.
But for COX this doesn't seam right to me.
Clark (if you'r out there), was your comment for log rank only, or not?
Re Fuzzy interim goals make no sense...
"Rancherho framed the question from "an ethical point of view." And from an ethical POV, it makes a lot of sense. Since when is thinking about patients 'wishy washy' logic? "
It's "wishy washy" because if some value above the SPA target is where the DSMB should stop the trial, then that is what the SPA should call out.
You can argue that the manner of alpha distribution is not in the best ethical interest of the patients, and I think many would agree with this. But this is up to the FDA and company to determine, not the DSMB (which is just acting as an indpendent party who can peek into the data w/o unblinding the trial to the company).
Simply put, the company and FDA have informed the DSMB that the trial should continue on at P=.011, if this is wrong ethically don't ask the DSMB to fix it.
[.01 is for example, I do not know it this is the real number]
Fuzzy interim goals make no sence.
If you think a higher P value should cause an early unblind, then that should have been in the SPA. The company has the flexability to do this.
Near misses are just an excues for poor thinking/planning. If they want a P=.011 (for example) to cause termination, just say so in advance formally. Why allow some wishy washy logic on a very simple decision tree?
I do think there could be cases where other compelling data could effect the issue, but even so the DSMB is not going to lightly override the trial design.
In short, I have no idea if it has ever happened but I find the concept very illogical (and certainly very un-beurocratic).
RE: DSMB and the interim peek
I have always thought that the DSMB just used the prescribed goal for an early stop, and if not met keeps quite. Thus the DNDN would not know the P value is a near miss.
Even if somehow the company does have the data, I doubt the FDA would like an early stop when the SPA defined P value had not been met. The FDA in general does not like changes to trials in progress, especially if based on data from the trial.
The "dark side" of T replacement
I know we generally don't discuss this, but one has to seriously ask how much of the Androgel class drugs go out back door?
If this is signifcant (and I strongly suspect it is) then the EU approval would be almost as good as FDA.
Yes, I understand that Andoroxal dosn't raise T to supra-normal levels, but there are still many who will opt for it because of the side effect profile.
Yes, stuff like this is why the Andoroxal partner will not be big pharma. But it's also why And. has more value than the FDA process implies.
Brean Murray ...
Let's try it this way.
IF Provenge does not work, then obviously a lager tral is more likely to fail.
IF Provenge works, then it is more likely that a large trial succedes.
SO...
Brean Murray says in effect, "We believe that Proveng does not work, so the Impact trial should fail"
Let's call BM BS for now.
RE: SPPI vc GPCB
On the substative issue of the Pharm. outlicence I must admit I am a little confused.
Would the SPPI/GPCB contract call for a share of the retail level revenue? In which case SPPI was uneffected and I don't even know why they whent to arbitration.
If the contract calls for just a percentage of GPCB's revenue, then I would think they had a clear case (unless they totally f'd up on the contract).
Any clues here, Due?
I agree the rest of the issues were always stupid.
BTW, If this is good for GPCB, will the GTCB pps go up?
RE: Is this a hoax?
No, these concepts have been tossed about for a few yaers now. Expect enough initial pushback that nothing much comes of it for a few years.
But it will happen. The UK has been playing with this for a while now.
You are right about points. These tickets will work like the red-light cameras, just a fine against the car w/o any driver license offense.
Of course the big loss of privacy will be when the info is available on "Google auto tracker" and your wife will know when out drinking with the boys (as opposed to working late)
QUIZ: % of disposable income spent on health care within age brackets.
RE: memory Pharma.
"The 50 mg group also showed no statistically significant differences favoring treatment at any endpoint in the study."
Since in other places they didn't include the "favoring treatment" clause, one must assume that some endpoints were stat sig in favor of placebo.
There are actually 9 primary endpoints (3 arms, 3 points each) and we see 2 hit stat sig. What about the rest?
Sounds like the data is a little murkier than let on.
It woud be nice if companies would just present a table with all endpoint data, I guess I live in a fantasy world though.
GTOP MyVax P3 trial data soon.
The last patient follow-up fr the trial of MyVax in follicular NHL is in November, the company says top line results by EOY.
The stock price took a big hit over a year ago when it missed having an interum reach the P value goal. Then Aschroft (who had been a big backer) went negative.
My assumption would be that there must still be a decent chance to hit stat-sig else the trial would have been stopped for futility by the DSMB last year. As such, it seams like a decent gamble (obviously not a shure thing, as if so the interrum would have hot it's goal).
Is there anything in this makes this any worse than my view?
Hey Crou, I got 2 inutes also.
"1) Why do large wall-street houses pay exhorbitant amounts of money to analysts so that they give their opinion for free to the public? Are they a charity or is it manipulation?"
I agree with Crou here on this one somewhat, much "research" is published to push sales of whatever.
"2) Why does wall-street allow shorting (legal or naked does not matter). Is it really for "liquidity and efficiency" or is it for manipulation?"
Strongly dsagree. Shorting is also the most effective counter to long side manipulation and/or pumping. It's not really liquidity, but establishing more of a valid market (when things arn't being gimmie'd by funds shorting into pipes, etc.).
"3) Why does the financial media (including CNBC, Forbes, Wall street joornal, reuters, and all the rest...) put such a concerted spin in reporting about stocks and companies, and why is the spin always identical for all the media? Is it to inform the public or is it because they get dictated to them by the crooked hedgies?"
How about my assumption: the media just plain sucks?
Personnally, I like the fraud theory.
Somebody on biotechvalues suggested that it was possible the brokers thought the buy yesterday might have been fradulent, and they were stopping all online trades for that reason.
Makes a lot more sence than any other explanation.
This has been a known problem the last few months, hijacking on on-line account to make trades in a thin stock so you can profit on from the price distortion.
[The trade did look VERY weird]
The problem is you can't put up the money.
Going short always involves borrowing stock. Even if you have the cash in you account to cover the value of the stock at the time you short, you still have a potential liability.
The SEC has long ago ruled that they will simply apply standard margin rules to the borrow. And that's why you can't short it.
Of course they have many other rules that intentionally favor big investors. All to "protect" the little guy.
For a good start at fixing this crap, how about a real version on regulation FD. ALL communications by a company wrt fininacials etc are made electronically in the open. If an analyst wants to ask a question, do it on a chat board or blog or such. Call it reguation ED.
But that won't happen.
"I should have asked if they have some security catch to prevent fraudulent trades that kicks in when a security moves too far up and down (or vice versa) too fast. But I didn't think of that at the time."
That's a very good theory. There has been some fraud issues recently where hackers get access to somebodies account and use it to make bogus trades that they take the other side of.
Certainly the pattern of a very isolated volume/price spike would be a good trigger. If I was the person tasked with looking at this, I would pull the alarm switch, at which point no more online trading would be the obvious action.
As a follow up, the question is "Was the spike (and the exceptional bid the day before) fraud or not?"
I am sceptical that the action was due to leaked news, because of lack of followup.
I did consider the possibility of a margin call on somebody who had 300k IDIX short. This would explain the patient attempt to buy (while the customer tried to buy back), followed by the quick buy in when the broker said "times up".
But a fraudulent trade makes equally good since.
[BTW, for those who don't do margin. A margin call applies to an account, not just a stock (like most mb poster kiddies imply). Thus a margin call related sell/buy does not need to be related to a stock that has moved significantly].
Re: scottrade IDIX issue.
If he was on margin in the account, then yes they can make account specific rules. A good example would be if the account was hevy in small biotechs.
But for a cash account (or a margin account account that has a net cash positive position) that makes no sense.
Interesting that somebody over on Yahoo! made the same point about E-trade a few hours ago.
I really don't know if this is something very strange, just a mistake, or total BS (no accusation intended, just listing the possibilities).
Don't talk to me about what ifs,
I've been trading in and out of TMTA the last 6 months, and I was OUT this morning.
I just went out to buy a new crying towel
Perhapse Pfiser has a drug that will help us?
IDIX, no conspiracy theory.
I'm not into reading tea leaves off of stock charts, but in this case the volume (and bid size) does look like somebody wanted to aquire a few hundred thousand shares. They were patient earlier this week, but decided to got impatient today.
Whovever made the buy acts like they think they have news.
Scottrade won't let you buy IDIX online, huh????
Are you using cash (vs margin), or is Scottrade weird, or what?
I certainly wouldn't take that crap from a broker, too many choices out there.
Not clear to us,
But whoever just got impatient in buying over 1 million dollars worth of IDIX thinks they know
IDIX - Well, somebody has the news (eom).
Whats up???
Because they think the price will drop?