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RE: MDT Wins ‘Preemption’ Case
"I really can't see the distinction here between a medical device maker that gets FDA approval being absolved of any liability and a drug maker who gets approval from the same agency"
From the Times article:
"..that Medtronic and other manufacturers were protected under the Medical Device Amendments of 1976, which in its section on pre-emption bars states from imposing on medical devices “any requirement which is different from, ..."
So unless the same language can be found in the relavent code for drugs, it does not apply.
BTW: I really dislike this ruling.
This 30 days seemed strange to me,
but going to the FDA website you are correct.
http://www.fda.gov/cder/regulatory/applications/ind_page_1.htm#Introduction
From the IND FAQ here -
"When can I start clinical trials?
Unless you are contacted, you may begin trials thirty days after FDA receives your IND application."
I think the ZGEN delay last fall probably supports your argument better. They had a minor formality on a plant inspection well before PDUFA date, and got bumped 2 months. Arguably this could have been a big benifit to fundy favorite OMRI.
Maybe they were too busy trying to find that Chinease heparin plant
I disagree with you about DORB. The FDA was about to turn them down, when DORB submitted more matrerial after the AC and that caused the delay. The line "the FDA requested" never ment anything. It's like the judge saying "do you have anything else to say before I fine you".
"Feelings are something you should have toward your spouse, boyfriend, or girlfriend, or, if you are so inclined, livestock, most especially goats and sheep. If you buy, sell, or hold stock based on feelings, you are too emotionally involved with an inanimate object -- an intangible one at that"
A very precise and reasonable answer, but one that opens up to about 1000 stupid replies on THIS stock board
OT: re FDA and dev stage start ups
First, I said OT because I don't want this to be viewed as a slam on RPRX, it isn't.
To some extent, there as been an increase in FDA delayes due to workload (IMHO).
But we also have seen many companies hidng behind the self imposed secrecy to claim foul on the FDA. Any company has the ability to publicly release their communications with the FDA if they so desire. The never do. In the vast majority of the cases it would turn out that the company had some real issues that it needed to address. In the cases that actually go to an AC you can see this.
I am not saying the FDA is perfect, and I am not saying it is unswayed by BP. But they are not the evil monster some proclaim, it's not all one-sided.
I do agree that there are HUGE issues with BP consultants working in the FDA. Many of these get paychecks JUST because they have FDA ties.
Crou, now we are talking!
I thought DNDN was classic. Going into the AC I really didn't know what would happen, but I thought they had a chance (anywhere from 25% to 50% dependending on my mood).
DewD, AdamF also were similar (maybe 30% yes for both). BSR was more favorable (at least 50% I think).
So let's say they had 30% shot. The stock was at $4.50 or so much of that winter. If approved it would have hit $30 easily.
Some people don't understand risk/reward.
The trick here is to avoid being bled to death when the companies need financing to buy time.
Re: NNVC
Thanks! Once I cash my profits on REFR and HEB, I might buy this
RE: Nanoviricides. Hows does this work?
They describe the concept as decoy cells. The virus binds to the nanviricide particles and then can not infect real cells.
The obvious question is how much is needed to be effective?
Is it even remotely practical?
RE: "So, if it is not manipulation ..."
The answer depends on where your position is in the time Q when the other asks match you. If you are first (as you should be), then I don't see a real issue. Very possible that traders with busted options have programs to match the current best ask.
On the other hand, if these guys get the orders ahead of you, that is bogus.
<extream sarcasm>I'm certain the SEC would crack down on that though. </extream sarcasm>
RE: "and now exwannabe will have to wear it."
Actually, I get to wear the dunce cap no matter what happens because I simply didn't spend enough time tring to figure this out on my own before posting.
Now that I have spent some time, I believe that -
The FDA views the safety issues as somewhat different, either because of the shorter schedule (dewophiles theory), or because of the likelyhood of higher doses (DewD's theory).
If the put it all under one IND, then that might risk delaying everything for an issue that effects ony part of the studies.
It seams very unlikely to me that the new IND would produce a "COR like" delay, but I think anytime you put paper in front of the FDA some delay is possible.
So there you have it, my final non-answer.
I shall not shut up on this
"The Phase One trials are already done - in fact the Phase One trials do not have to be in patients with the particular indication - or have any disease or condition at all (they can be "healthy" volunteers)."
I know this.
What has me confused is the new IND. I always thought the IND was kind of the "safe enough for human testing" signoff that submits the pre-clinical safety and defines the phase 1. Once passed that the IND and P1, the company just does P2 and P3 for other indications.
So what does the new IND mean? Normally I would have assumed there is something signficantly different about the usage in te new indication that would make the previous IND/P1 not valid. But in this case (it's still women with fibroids) I don't see why this would be so.
I really have no idea if I am just misunderstanding when the FDA asks for new INDs, or there is something weird in this case. I did hear the company's "it's cleaner this way" statement, but that seams odd to me unless it is always done and I don't here about it.
Oh well, I probably never will understand the inner workings of the FDA.
Good luck all.
Thanks Dew.
Yes you understood my last Q correctly (execpt I don't think Congress counts here, it's the FDA that will implement the details on any FoB legislation which was my Q).
Q on FDA enoxaparin generics issue.
Is this immune issue likely to be general question in the FoB space?
[OK, I known that technically heparins are not biologics, but that seams more like govenment nonsence to me than science]
If so, could MNTA get a nice adavantage in the FoB space by both getting a better understanding of the FDA requests, and also by pushing their views on achieving biosimilar status?
I'm clueless here
Q on IND and trial protocol.
I thought that an IND always specified the P1 safety trial to be done. Comments?
RE: I believe non-institutional investors should get the same opportunities as larger holders and analysts ...
I don't have a problem with this, as it is a practicality issue.
My problem is when they want to get past the fluff into the important details they take it off-line. There is simply no raional reason (by which I mean in the interest of the investors) for this process in todays world.
If they don't want to provide the information on the call because it would just be unwieldy, then do it via the net (msg board, email list, whatever). They can still filter/moderate what they accept as question however they wish, but all responses are public.
Replace reg FD (Full Deception), with reg ED (Electronic Disclosure).
WAY OT: Google's new free broadband.
http://www.google.com/tisp/
You got to credit this company with a good since of humour.
Jessey, you are way off base.
To start, not only am I not bitching about the PPS and paper loss on such, I bought more on the dip and if things go well I will make a larger profit thereby. You are really projecting something on to me when you imply I am just unhappy, as I am not in the least. I quite well understand that investing in ANY startup biotech carries a risk of total loss.
Should I have sean it comming? Good question. I certainly did see a reasonable chance of a serious hit due to financing. I did not want to be out of the stock though because I certainly thought they had a good chance to get the partnership deal. I did keep extra cash ready just in case. I am very willing to roll the dice and take the hit.
I never accused Cox and co. of being morons, I said they got the decision wrong. As a Monday morning quarterback, I AM a genius
The issue is not who/what/where. It happened and I could care less exactly why. All I care about is that management sees that they will be quickly in the same position, and hopefully have it better planned.
BTW, anybody who cares about the Safe Habor statement is more naive than my 10 year old daughter.
"They may have failed to understand another’s fraud, or greediness"
NO, they failed to understand their own cash position.
The basic situation was very clear. They had a burn rate, and a time 'till revenue. They needed to have solid plans in place, and they obviously didn't.
This is really not complicated.
"we know nothing"
WRONG! We know there was a significant dillution, we know they could have minimized it by acting earlier.
RE: MNTA and 2 friends
Since $2 is just over half of cash, that seams a little harsh.
And CTIC is back in the news.
Could "death spiral" be a good description.
http://biz.yahoo.com/bizj/080214/1591771.html?.v=2
BTW, is there a record for the NASDAQ company that does 2 reverse splits the fastest?
On the serious side, it's kind of sad that both their 2 real drugs (Zyotax and Pixatrone) might well have made it to market in the hands of a real company.
RE: If investors don't concede that simple fact, then more trouble lies ahead.
Huh?
If you mean more trouble for those investors in whatever they get into next, fine.
If you mean more trouble in GTCB, that would be absurd (unless you live in the fairytaleland where ownership has some influence on the BOD).
[I agree with you on the main argument]
RE: "Am I late to this party:"
Hell no, we all were too early
Re Cox, specifics.
The finance deal, obviously.
It may well be the best that could be negotiated at this time, but that is irrelavent. They should have got the cash earlier.
As far as I can see, there has been no great surprise in the burn rate and the commercialisation schedule over the last couple years. So the cash issue was easily predictable.
You could argue that Cox and co. expected the partnership deal to take care of that, but if so he was taken a significant risk, delays happen in biotech.
When you need financing, do it ASAP. The longer you wait, the worse the deal is (as we now see).
As to remmidies, the deal is history. Going forward, I would hope that they have learned the lesson.
Due process? This is a message board, we perform verbal lynchings based on no evidence
BTW, I am not anti-Cox here. Clearly a failure at the senior level has occured, but I know nothing as to who was the culprit (but Cox gets the default blaim as captain of the ship).
Briefing's buy rec from BM
Perhapse somebody got confused with the letter BM sent to their institutional clients vs. the retail crowd?
"I am not sure what legislation you could write"
I have one easy one. Reg FD sucks. We still have CCs where we here analysts say they will ask the question offline (and the devil is in the detail).
Here's a real easy solution:
ALL communication from the company is public. If some analyst needs to ask a question, send it via a MB or such where all can see.
RE: ZGEN and Brean Murray hit piece
Kool!
Was getting a little bored today (to cold for golf), so I think this will be a nice time to buy some more ZGEN.
IDIX quiz. To reduce cost?
Whoops, missed your hint. forget this answer (that I thought was dumb anyway).
I give up.
RE: "They are focused on the goal"
Shouldn't that be "They are focused on the goat"?
Seriously though, most on this MB are more interested in the long term (both financially and technology wise), not just the day to day price fluctuations. So, if you feel like hanging around, this is far better than Y! or the others.
Cheers.
But the audio skipped any mention.
INGN, the ADVEXIN NDA of course.
The orriginal gameplan had a few minor setbacks :
. The 2 P3 trials never completed enrollment
. The anyalysis of the aborted trials showed it failed
But this hasn't stopped INGN from it's glorious mission to bring ADVEXIN to market.
Alas, since then they had a few more setbacks :
. One trial has vanished from the face of the earth.
. The attempt to data mine a subset on the other trial failed.
So this caused a further delay, back to the data mining. It seams they are now trying to find more long term surviving patients to add to the subset of P3 deficient ones in the ADVEXIN arm.
And for over three years now the NDA has been about ready to be submitted!
The odd thing is that in the time they have spent on this charade they could have run a correctly designed P2 to see if the drug really works in the presumed subset they have in mind.
Data from off-lable Atryn for DIC
Since plasma antithrombin is already used for DIC in Japan, this would likely be a better source of such data.
For example :
http://www3.interscience.wiley.com/cgi-bin/abstract/112760171/ABSTRACT?CRETRY=1&SRETRY=0
[I think it would be near impossible to distinguish the effect of Atryn vs. antithrombin by looking at historical data]
"Problems in Blood Drug Lead to Halt by Factory "
Baxter's heparin mfg is broken. Hope they can find the problem soon.
http://www.nytimes.com/2008/02/12/health/12drug.html?_r=1&adxnnl=1&ref=us&adxnnlx=1202821492-oxeLjkNXwdNYEBOXEW0nRg&oref=slogin
SPPI - Valuation for LFA if approved?
SPPI's LFA (the left isomer of Leucovorin)has a PDUFA date in early March. SPPI has the N American only rights, and the drug has been sold for quite a while in the EU (sales over $180mm).
With a present market cap of 83M, it seams like they could get some pop on this.
The potential drawbacks I can see are :
. I assume they pay a hefty royalty to Merck Eprova
. Little visability in what whent wrong with the earlier CMC based aprovable decision (SPPI picked this up from a bankrupt company that never disclosed much).
. The indication doesn't include colorectal cancer, but SPPI plans to file an sNDA "soon" afterwards.
On the other hand, this seams like a very safe play, in that the drug has extensive use in the EU, and it's just the active isomer of the existing SOC.
Given that the company does have some pipeline products (Eoquin in P3 for bladder cancer is the most advanced), and the market cap is barely above cash, it seams the market values LFA at about 5 cents.
What am I missing here?
RE: INGN management spin .. at the worst.
Agree, but I think IDMI is running neck and neck at the turn.
While INGN is trying to find tissue samples of a long ago unblinded study to support a post hoc subset analysis, IDMI is trying to find still breathing patients on a long abandoned study to hit the secondary OS endpoint on an open lable study.
I honestly am sorry for people who invest in these companies.
RE: SCLN numbers.
You missed Dew's post where he referenced the latest large study here where the SOC came in at 9%.
Given that the trial is probably running at 11% (w/o dew's unlikely assumption about remaing patients), that gives 9% vs. 13% for the 2 arms.
This is well withen the "noise" error when looking at unblinded data.
RE: $378B savings
A study commissioned by a protein manufacturer.
Can we next post the '60 era tobacco studies?
BTW, maybe the number is even right, but the source is worthless.
mouton, no I missed this. LOL.
When I saw the "announcement date" it was so obvious to me they would use the day BEFORE (not after) as the cut date that my mind read it that way.
RE: Warrents and the B-S based payout.
This sounds kind of wrong to me (I mean wrong in the sence that the valuation will be too high).
The price premium paid for a buyout is mostly to pay as compensation for the future potential of the stock. And B-S is doing the same thing in its way.
But the B-S valuation in this case is calculated on the buyout price. Thus, the warrent holders get the "negotiated" payout for future benifit along with the calculated one from B-S.
IMHO, it would have made more sence to calculate the B-S value based on both volatility and price before the public announcement, and give the warrent holders the better of the two prices. MAX(B-S value, buyout price) - .87
GTCB - a sucky finance deal EOM.
RE: partnership poll.
I wanted to vote for Bayer, but was afraid that if this really happened we might have a massive Thrombin - antiThrombin explosion