Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
"GTOP – The higher PFS in the “responder” subset merely means that people with a strong immune system are in better shape medically than those with a weak immune system."
When questioned on this exact point, the company twit said he didn't understand the question. Then he said this was not the case because the data was against a control arm.
Either this guy is too clueless to have a job in this field, or he should be in jail.
GTOP, yes the CC is BS.
On the 15th question they finally pryed the primary endpoint P value out of the dude. P>.1
We still never heard the P value of the responder subset analyses, or much of any other numbers.
BTW, and WTF!
The company said in response to a certain questioner that they would give that information later in a private meeting. Perhapse the SEC should enforce reg FD when the company states publicly in a CC that they intend to ignore it.
GTOP trading.
I don't buy the "after hours" theory, becasue bad data could easily have been delayed into Christmas if the company wanted to play that game.
Maybe some traders who were playing the "buy 'till the runup then bail" and got caught, or maybe a leak.
We will know soon
There is SOME bad news in the PR.
This makes it very unlikely that antiThrombin can compete with Ampligen as a miracle cure for everything
INGN latest PR, straight from Comedy Central.
http://biz.yahoo.com/bw/071220/20071220005137.html?.v=1
In short, after data-mining their aborted P3 trial for a year, they decide they need more ore to shift through in the attempt to find gold.
The good news is that in 6 months we will here another excuse. I predict "The dog ate my homework" line
BACKGROUND: Before anybody foolishes wastes there time looking at this company (like I did), here's the Readers Digest summary. They have a drug that might be effective in cancers with a defective P53 gene. They ran a pivital trial, and it never enrolled (actually 2 trials, but the second one was abducted by UFO's). So eventually they just looked at the data and it obviously was a no go. So then they decided to do a subset analysis, which required them to get data they didn't think of in advance. Now they want to go back again to paients and get more data. Through this whole process they insist they have always been 6-12 months (or less) from a BLA submission.
"Where do you see MNTA in ..?"
Still on the NASDAQ
Seriously, I have no clue, nor do I care.
All I ever do is buy companies that I like. More so if nobody else likes them.
If you want a serious answer, I expect a slow recovery to $10 or so.
The chicken bones I tossed on the sidewalk said so
Sorry for the terminolgy issue wrt "busted".
I just meant any company that took a big hit on bad news.
Those companies that are busted by your definition are quite worthless, they will spend the cash and be gone.
Certainly was not placing MNTA in the trash bin catagory.
"So my previous fears ..."
I swear, at time I think Crou is the Mel Gibson character in Conspiracy Theory
MNTA, just recovering from insanity.
That's why I so like bottom fishing.
Serriously, is so much easier trying to buy "busted" biotechs. Not only is the bad news gone, but you have the chance the stock is overly depressed (as opposed to a flying biotech, where you pay a premium).
"If the DTRA happens, aren't they obligated to PR it within so many days? "
No, this is a common misunderstanding of regulation FD (sic).
The rule is that IF the company discloses the information to analyst/fund/banker types THEN they must publicly disclose withen a short timeframe.
As long as they don't let there favorite Wall Street boys know, they can keep quite.
BTW, regulation FD is a farce. The day or so they allow is plenty of time to rape the reatil guys.
A real regulation would be to require all such information to be transmitted via open internet channels. The company could thus disclose whatever they want to their favorite analysts, but eberybody would know real time.
But, the SEC has no interest in really addressing the leaked info issue.
Insider purchases wrt SEC.
News on trial results would not be a problem, because he would not have known the data at the time he bought. Nobody knows trial results before unblinding.
As to a partner, as long as the status was reasonably consistent with the public statements, that is fine.
Problems would be if he had already inked a great deal (or already had top line results in hand).
The amount of the buy doesn't matter. But in practice, the SEC would obviously not care about a minor purchase. The only recent case I remember of the SEC taking action on a buy was when Murdoch bought DowJones, and some guy from Asia bought a ton of calls before the news was out.
Re: Nice entry time after sell off.
NOT
Oh well, I just 2x'd at .72 and am done. I think it's time to shove this under the mattress.
Right there with you at exactly $1.
Probably make some more beer money trading them, but who knows? Perhaps some good news hits while I am long (don't see any bad news on the horizon).
PANC: Bev. results for 350mg group not impressive
Many hoped this group would do better than the 300mg group, and it didn't (though, perhaps only because of absorbtion or clearance issues since the serum level was lower for the 350 group)
Also, I think many are viewing a 1.0log10 viral reduction as kind of the "mark" to hit, and now Bev is not there.
I didn't here the CC, but it seams the company is going with the "it works well for some" story, which always raises a flag (and they had no need to do this, it was a N=10 trial after all).
Might be a buy under $1?
Time value of puts as P3 top line data awaits.
I have sold quite a few GTOP Dec puts over the last month. Not because I think they will have good results on their upcomming trial data, but because I think the results can't come out that early (and if negative, they will wait till at least the holidays).
So here's the general question. Is it virtually certain that for small biotechs top line P3 data will be delayed for at least a few weeks if it is bad? Is this a playable effect?
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.