ViroPharma Incorporated (VPHM)

[surf1944]

VPHM down 50% in a week, getting closer to a buy area.

[surf1944]

ViroPharma Incorporated Reports Second Quarter and Six-Month 2007 Financial Results and Amgen Responds to Final CMS National Coverage Determination

Biotechnology industry alert provided by U.S. Equity News. ViroPharma Incorporated (Nasdaq:VPHM) recently reported its financial results for the second quarter and six-months ended June 30, 2007. Highlights since March 31, 2007 include: Clinical Pipeline: Phase 3 study of Camvia(TM) (maribavir) initiated in liver transplant patients and trial opened to patient recruitment and Enrollment completed in the 500 mg BID arms of Phase 2 study of HCV-796 when dosed in combination with pegylated interferon and ribavirin

U.S. BioDefense, Inc. (OTC BB:UBDE) recently announced the company will proceed with the spin out of its wholly owned subsidiary Emergency Disaster Systems (EDS). The company plans to file Form SB-2 Registration Statement with the Securities and Exchange Commission to distribute shares of common stock of Emergency Disaster Systems. . Although a record date for such distribution has not been set, shareholders of UBDE will receive as dividend shares of the new entity.

Amgen (NASDAQ:AMGN) recently announced its response to the Centers for Medicare and Medicaid Services' (CMS) final National Coverage Determination (NCD) on the use of erythropoiesis-stimulating agents (ESAs) in cancer and related neoplastic conditions. Based on Amgen's preliminary review, it appears that CMS has adopted a policy that will limit the availability of these vital medicines to Medicare beneficiaries with cancer.

Invitrogen Corporation (Nasdaq:IVGN) recently announced results for its second quarter ended June 30, 2007. Revenues for the second quarter were $322 million, an increase of 13 percent over the $285 million for 2006, excluding the impact of discontinued operations. "The intense focus we placed on operations, IT infrastructure and integrations during the last twelve months is delivering results," said Greg Lucier, Chairman and Chief Executive Officer of Invitrogen.

[MikeDDKing]

I made a post on the Value Microcap board regarding vancomycin generics. Please look at it if you haven't read it over there.

http://www.investorshub.com/boards/read_msg.asp?message_id=14193593

Mike

[Thor_Johnson999]

VPHM article by the Stockmasters - how they got Pamela Anderson in here I don't know, it's a really good article on VPHM though

http://thestockmasters.com/stock_vphm_10192006_1.asp

[MikeDDKing]

Below is a link to a very useful and positive article on VPHM. This was originally posted by Zen lunatic420 on the Value Microcap board. I recommend that any current or potential future owners of VPHM read this article.

http://www.vitalstocks.com/blog/2006/05/vphm-viropharma-inc-at-9-upgrading-to.html

Mike

[Golden Cross]

VPHM - ViroPharma Files Supplement to Vancocin Petition for Stay of Action
Wednesday May 31, 5:29 pm ET
- Scientific Supplement Also to be Filed This Quarter -


EXTON, Pa., May 31 /PRNewswire-FirstCall/ -- ViroPharma Incorporated (Nasdaq: VPHM - News) today filed a supplement to its Petition for Stay of Action with the FDA regarding the bioequivalence requirements for abbreviated new drug applications (ANDAs) that seek to copy Vancocin. The document sets forth legal arguments in support of ViroPharma's strong belief that the decision of the FDA's Office of Generic Drugs (OGD) to lower the bioequivalence standards for generic copies of Vancocin violated numerous federal statutes and FDA's own regulations with the result that the new standard cannot, as a matter of law, be used in the review or approval of applications for generic versions of Vancocin.



In addition to this filing, ViroPharma intends to supplement the Petition for Stay of Action later this quarter with a filing containing scientific arguments that show that the OGD's new standard is unsupportable as a matter of science.

The filing made by ViroPharma today can be viewed in its entirety on ViroPharma's corporate website, at http://www.viropharma.com/OGDpetition. The document is also being furnished today with the SEC as an exhibit to a Current Report on Form 8-K, and will be available on the EDGAR section of the SEC website as well as the SEC filings page of the 'investing' section of the ViroPharma website. The company also expects that the document will become available on the docket management section of the FDA website within approximately two weeks.

ViroPharma intends to vigorously oppose any approach that does not require rigorous scientific methods including human clinical studies, consistent with good medicine and science. The company also believes that, given the growing number of patients with severe, and possibly life-threatening, C. difficile- associated disease, the appropriate expert advisory groups must validate the scientific and medical appropriateness of the approval standards for a generic locally acting vancomycin capsule product.

C. difficile is a bacterium, which under certain circumstances, typically after antibiotic therapy, can colonize the lower gastrointestinal tract where it may produce toxins which cause inflammation of the colon and diarrhea, and the associated complications of disease, including death. Advanced age, gastrointestinal surgery/manipulation, long length of stay in healthcare settings, a serious underlying illness and compromised immunity are conditions associated with increased risk of disease. According to the CDC, there are approximately 3,000,000 cases of antibiotic-associated diarrhea per year, of which 15 to 25 percent are caused by C. difficile.

About ViroPharma Incorporated

ViroPharma Incorporated is a biopharmaceutical company dedicated to the development and commercialization of products that address serious diseases treated by physician specialists and in hospital settings. ViroPharma commercializes Vancocin®, approved for oral administration for treatment of antibiotic-associated pseudomembranous colitis caused by Clostridium difficile and enterocolitis caused by Staphylococcus aureus, including methicillin- resistant strains (for prescribing information, please download the package insert at http://www.viropharma.com/docs/pulvules_pi.pdf). ViroPharma currently focuses its drug development activities in viral diseases including cytomegalovirus (CMV) and hepatitis C (HCV). For more information on ViroPharma, visit the company's website at http://www.viropharma.com.

[stock_peeker]

Great news today that in 2H VPHM will be manufacturing product themselves vs. thru Lilly.

[nocheintyp]

Everybody please go to the new VIROPHARMA board

Hi @all, dear longs,

we finally have established our new, semi-private message board to where we have collected and still are collecting all the serious posters of the regular Y! VPHM board.

As one of the moderators I am urgently asking you to go there and apply for a membership if not yet been invited by me or either iceman or upndown (the two other moderators). You'll find it at
http://finance.groups.yahoo.com/group/VIROPHARMA/

Alternatively, or if problems during the application process may occur, please send me an email at [e-mail] that I can help you getting started.

I have to draw your attention to using email addresses that hold ABSOLUTELY NO PRIVATE INFORMATION about you in order to protect your privacy since the VIROPHARMA board is currently in semi-private mode (it accepts posts from members only but is readable to the public) and hiding of the members' email addresses to members is not possible right now. Of course, to the public ONLY email bodies, that is an email address cut right after the @-sign are visible. Should questions arise on this topic send me an email.

I hope to see you soon on the new board.

Greetings from Berlin

Jan (nocheintyp)

[mikeo56]

taken from the yahoo board

Quick Conference Call Recap
by: equitylongshort
Long-Term Sentiment: Strong Buy 03/23/06 07:46 pm
Msg: 109490 of 109540

For those of you who missed it, you can hear a replay of the Goldman Sachs conference this morning at: 800-332-6854 (US) or 973-528-0005 (Int’l), Passcode: 33154.


ViroPharma stated at the beginning of the call that it would not disclose anything new, however, it did elaborate on a few key points and confirmed some prior statements. Most importantly:

1) FDA wrongly classified Vancocin as a type 1 drug when it is in fact a type 3 (no permeability). This means that Vancocin cannot easily enter the bloodstream and so a bioequivalence waver does not apply for generic candidates.

2) FDA "decision" is actually a recommendation only, and was made by a low level employee without consulting the appropriate staff at the FDA responsible for classification, and without consulting published FDA guidelines

3) Viropharma is heavily working behind the scenes to cancel the recommendation and will not disclose these details until the plan is complete. VPHM has a strong game plan which is in motion now.

4) Maribavir Phase II is complete (last enrollment November '05) and results will be announced by the end of March (next week!!!)

5) Maribavir Phase III will begin as scheduled mid year in stem cells, and end of year in organs, indicating that all is clear in Phase II!!

6) Viropharma is in a strong cash position with no debt, solid prospects in the pipeline, and has revenue from SGP from it's licensing of a common cold treatment (there is nothing on the market right now to treat the common cold)

All in all, listening to the call has more than ever convinced me to hold VPHM no matter how low it goes, and to buy more on any weakness. There are a lot of false ideas out there and when the dust settles, VPHM will be back to the 20ies. You may only have to wait until the next earnings release, but don't doubt for a second that when the FDA does a mea culpa, VPHM is going up 3-5 dollars in one pop.



Posted as a reply to: Msg 109464 by zracer240z
Message Thread [ View ]

[upndown1313]

GENERIC MANUFACTURERS RISK

1. Unknown bioequivalence requirements

Company is claiming a this is a BCS 3 (high solubility/poor
permeability). Only BCS 1 compounds get biowaivers. Current FDA guideleine is only appropriate for compounds whose pharmacology depends on systemic absorption. Vancomycin is special case since it is not absorbed to a large extent due to poor permeability and works locally in GI. Working group RECOMMENDED a change in classification for this special case however there was no external discussion.Final discussion could take many, many months with outsideconsultants, clinicians, etc. Any inkling at all that dosage formimpacts efficacy will over turn the recommendation since this is for a life threatening disease condition. This represents high uncertainty risk for generic given the extreme pressure VPHM will put
on. If no decision soon, this effectely delays generic intrduction day-for-day. What I mean by this, this would be high risk for generic to initiate all the activites, w/o knowing the final outcome.

2. Unknown development, manufacturing issues requiring specialized equipment and tightly controled processing conditions.

Will weed time to re-enginer Lilly product. Could take 6-12 months once final equipment is installed and ready. Will also need to mitigate risks by taking several prototypes into parallel development which is very costly , time consuming, and resource intensive.

3. Unknown stability requirements.

Likely to be classified as complex dosage form due to specialized
manufacturing process. Cobsequently, will likely need long term
stability data at the time of filing from final mfg site. Appears the drug may have many stability issues, so even longer term stability may be required depending on the interim results. This represents a high uncertainty to rapid filing. Prabably the highest timing risk.

4. Financial

Intoduction by several generic manufacturers and newer products at same time would lower cost and ROI for this still relatively small product.

[mikeo56]

off the yahoo site

I just spoke with Will
by: iceman3223ice 03/21/06 04:11 pm
Msg: 107643 of 107941

Will just called me back from calling him early this morning:

1) The marabiver announcements will be out by the end of this month. I told him I was concerned that bad results leaked thus the reason for the huge drop. He said that they are still compiling the results and that because each doctor only has part of the picture, even if they wanted to breach their confidentiality agreement, no doctor involved in the study knows the outcome of the results. He also mentioned that everybody was very happy with marabiver although he denied that they had any advance knowledge of the results.

2) They were shocked by the FDA decision, which amounts to the FDA might, not has, allow a generic Vanco to not undergo clinical studies. He stated that there are two parameters to avoid clinical studies under FDA regulations, the drug has to be both soluble and permeable. Vanco is soluble but not permeable and therefore there should not be any waiver. So VPHM is going to take all steps necessary to ensure the FDA complies with its own regulations. That being said, he could not clarify how far along any genetic manufacturers are, but its their best guess they are still years away.

3) As for tolvemer (forgive my spelling), they expect it to come to the market in late 2008. Will again reiterated that Tolevemer may cure the symptoms but not the disease. When I asked about the recurrence rate being lower than Vanco, he responded that it has been tested on only mild to moderate C-diff patients and that Vanco is still the only drug available to treat Severe C-Diff where the toxins are already damaging the body, and which is the type spreading throughout the country. He says Tolevemer has never been tested in severe c-diff patients because of the risk the patient would die. Makes sense to me.

4) The FDA apparently changed its tracks midstream. It probably comes from the quack appointed by Bush to head the FDA (that comes from me not Will, but he didn’t disagree).

Anyway, Food for thought.

[zacko1223]

I guess the good thing from all this is that the SPO hangover has been forgotten with all this generic news and obviously the biggest catalyst here will be the maribavar results. Analysts want to know that there will be a profitable drug in the market sometime in the near future. Even if vanococin revenues drop in years to come due to a generic replacement, other revenues will be in place to keep the company operating. Vphm currently has I believe 2-3 in its pipeline and is looking to purchase one other.

Personaly. I think any purchase here under 12 will get you a great return in 6-8 months. Nobody really knows where the stock will be in 12 months, it could be at 15 or 50???....Investing requires 2 fundamentals, limiting your risk and maximizing your returns. I think the later is definately in our favor.

JMHO

[upndown1313]

Steve, don't disagree with anyhing you said.
Uncertainty and fear were the key drivers leading to Friday. The good new is, is that any good news will increase the pps such as Maribavir. As you said, this will take some time, prabably months for pps to recover to any large extent. I sold allot of my shares prior to the sell-off, but still have a sizeable position and am holding Long. Too many good news coming I feel.
The generic issue is now off our shoulders and will resolve itself in time. This will accelerate VPHM's transition to a true biotech company with a pipeline. VPHM used to be a $30-40 stock. Now with this I will have to live with it being a $20-30 stock.
As I said before, with both Vancocin and the pipeline being fully discounted by the market, any good news will lead to increased pps. We couldn't say that before.

By the way, if you haven't done so already, pleade send nocheintyp an email to get on the Yahoo user group for VPHM. We would love to have you.

[stevecapitolhill]

Uncertainty does not/will not enhance p/s

As many have said, and many more have observed and realized with substantial monetary loss, uncertainty is not rewarded with an increased p/s and is NOT to VPHM's advantage IMHO. While the discussion may have just begun, the recovery will probably languish within a narrow range or at least well below previous levels until there is some resolution of the issue of accelerated approval of a generic or other positive news is announced, and even that will be mitigated by the lingering doubt. I hate to be pessimistic and, in fact, have bought more at these low levels, but be realistic. This company has a specter hovering above it that has to be dispelled absolutely before any near-term recovery is to be realized. Furthermore, we won't know about progress toward a generic because the developer is probably not going to divulge that soon. It is, in fact, sheer speculation, albeit probably true, that Akorn is targeting vancocin. But absent that disclaimer, there is going to be a drag on VPHM that will hold it back until there is public resolution of the generics approval process issue. VPHM may advance marginally on the basis of other pipeline news, e.g., Maribavir, but the market has spoken, and it doesn't like the PROSPECT of an early generic and is not going to discriminate between a 2008 or an early 2009 one without other significant revenue enhancements, such as a price increase, alternate driver purchase, and (not and/or) positive clinical pipeline results. I feel this will be the mindset for some months because the alternate revenue sources will take time to become productive and bashers will constantly deride the probability of success or some other aspect of other drivers, but it is just my humble opinion. I don't like the distance of the horizon to success, but I think it is foreseeable barring failure on regulatory, clinical, or managerial efforts. Since that path is going to take some twists and turns, be realistic and be patient and be prepared to wait this out. Long term is the key, not quick fix.

[upndown1313]

Seems like ths was the recommendation of a FDA working group. The group notifed VPHM of it's outcome. It would seem to me that the discussion has really just started. VPHM initiated a stay of decision, and working group or maybe GI division opens additiional discussion. Once this gets on the docket, it becomes public knowledge. I would think these discussions could go on for some time, with VPHM given chance to state case and mayb e bring in outside consultants, such as the Prof. from S. Carolina who discoverd the new NTX treatment. This was presented to us a 'done deal' but I don't believe that is the case at all. As level of ucertainty decreases, the pps will rise. it will be intersting to see how delays in final decsion would delay any potenial ANDA filings. Would a potential gneric proceed on risk, if this decision is prolonged for many months? I doubt it. Consequently, as the dicsusion is prolonged it is to Vphm's advantage, IMHO.

[hogfan2]

Maribavir...jmo...good news should help significantly...bad news will hurt significantly...overreaction either way at this time...anyone with knowledge on this product...thanks...hog

[ideal_1000]

updown, if the FDA comes out and states that they are going to open/allow hearings on this, would you expect pps to recovery any?

[warlord]

Tom, Thanks again for your very thoughtful response. I wish that I had your knowledge of TA. I agree with all of your thoughts but based on gut instinct and a knowledge of the fundamentals of the company. In times past the company responded to attacts with a Conference Call. The next day we would recover. It would seem to me that that approach, if done well with some substance would help the long cause. The two press releases on Friday didn't do anything but to confirm that there was a generic threat and that it was because of a decision made by the FDA. I am still shocked that the Canadian anlayst seemed to know about it before they did. Having said that, Plecfan on the Yahoo Board said that he had spoken with Will in PR at VPHM and that they were working on the FDA issue.
I hope that they will give us progress reports. That might help to support the stock price and give us a chance to get rid of the turbulence in the stock price. Just knowing where the botom is would be comforting after the past two weeks.
Thaks again for your time and thoughts. I really do appreciate it.
Dick

[upndown1313]

POTENTIAL TIMELINES FOR GENERIC

Someone needs to explain to me how a 2008 launch is feasible.

Let's assume generic started development in early 4Q05 and had all manufacturing already in place. This is an extremEly aggressive assumption.

I. STABLITY ON CRITICAL PATH
DEVELOPMENT - 6 MONTHS 4Q05-2Q06
SCALE-UP 3 MONTHS END 2Q06
STABILITY ON STATION- 18 MONTHS - 3Q06-1Q08
FILE ANDA 2Q08
APPROVAL - 12-18 MONTHS AGGRESSIVE 2Q09 -- LIKELY 4Q09

II. CLINCIAL STUDIES ON CRITICAL PATH
DEVELOPMENT - SAME AS ABOVE
SCALE-UP - SAME AS ABOVE
STABILITY - SAME AS ABOVE
CLINICAL START-END 3Q06 - 3Q08
FILE NDA 4Q08
APPROVAL - 4Q09-2Q10

NOT REALLY THAT MUCH DIFFERENCE. LATE 2009 VS 2010.

This looks like much ado about nothing.

Comments welcome.

[toheney]

Hello all,
Good to be here. I bought back half of my position (5,000 shrs) this morning. Time will tell regarding the generic. Many variables to try and quantify risk/reward so i did what I usally do in these situations, I just go for it! I really like the potential plec royalty from SGP. That alone is worth hanging around.
Anyway, it's good to be back with people from last year. Good Luck to all

[goldyfarbs]

I agree with everything you say. I am long on this stock as my Dad is a doctor and writes for this drug all the time.

But with that said, I do have some concerns.

I think this $10 drop downwards is more than a correction. As people are saying it is completely oversold, but what is going to take this higher..

I think its a little optimistic to say that this stock is going to $30 dollars by the end of the year.

I am really pissed at Jeffries b/c the fool.com article on thursday at like 3pm caused me to by more.

I feel like such a sucker at times.


The good news is that it bounced off of 9.70..

We need good news ASAP to help us bounce up..

[tom14100]

From a technical point of view to determine how low a stock might go you look for support levels. Bear in mind that news always trumps technicals so you could be holding a support level and if more bad news comes out it would blow right through it like a knife through butter. That said, let's dwell on more of the positive side. We are currently all but sitting on the strongest support level above $2. There is chart support around $9.75 and psychological support at $10.00. Below that there is a bit of support around $7 and after that $2. AFter today I suspect the $9.75 - $10 level will hold. There was tremendous volume today as clearly some big boys wanted to unload more shares, but there was also enough buyers to consume those shares without significant share price loss. Further the price dipped down and tested the 9.75 level and bounced off of it finishing in the upper range of price for the day. I think 9.75 needs to be tested further to substantiate that there is indeed strong demand when the stock gets down to those levels. Todays action seems to indicate to me that there are plenty of bottom fishers willing to pay around $10 - 10.50, but not much more. Based on the 10 minute charts you can see that demand picked up when the price got down around 10, but fell off when it got up around 10.50. It is looking a bit brighter that perhaps the blood is about to stop flowing. However, don't get to excited over one days action. I am of the school of thought who believes (short of a quick reversal of the FDA decision) that from this point, we need to build a decent base in this $10 area before we will launch forward again. Typically this would need take about a month or two, but I also believe that, lets say we stabilize here and three weeks from now they release strong results on Maribivar, then we should get a nice breakout. To get back up into the 20's I think it will take several positive news events, which is quite possible to happen this year.

[upndown1313]

GENERIC REQUIREMENTS

The most difficult part of the process will be to prove to FDA that generic can make a stable dosage form. Probably looking at 3-lots made at full-scale and having 18-months of real time data. Although this is an immediate release dosage form, it looks like it is produced using a non-standard technology. The formulation according the USP is a dispersion of vancomycin in polyethylene glycol. The product is very moisture sensitive and it is likely that these are the issues VPHM encountered when they did the transfer to Norwich. Based on my experience, I am sure strict control of processing, temperature and moisture is required in order to get a stable product. Whether or not CIPLA has the full scale equipment that can control to this level in place I am not sure. Even if they did, it would probably take well over 2 years to generate the necessary stability data. It is not likely that accelerated stability will correlate to long term, so they may to co-develop several prototypes in hopes that one is stable. Sounds risky to me, even without having to do clincial studies. Then add 18 -month appraval time and still into 2009, maybe 2010. The bioequivalence issue may become moot.

People need to look at all the requirements and assess total impact. Obviously that hasn't been done here.

OT: I love Zacks analysis today. They took credit for that crappy analysis, essntially telling everyone that they warned us. Well, their issue was not generics, it was the new product introductions. They were right, but for the wrong reason.

[oinchats]

FINALLY, A BROKERAGE MAKES SENSE


Monday , March 20, 2006 10:35 ET

Issuer: Viropharma, Incorporated (NasdaqNM: VPHM)

Analyst Firm: JMP Securities

Ratings Action: REITERATION

Current Rating: Mkt Outperform

Target Price Action: DECREASE
Target Price: $15.00 (-42.31% from $26.00)

Analyst Comments: VPHM has confirmed investor concerns that the Office of Generic Drugs (OGD) at the FDA had changed its stance on the data required for approval of generic Vancocin. Previous guidelines had indicated that a generic version of Vancocin would need to demonstrate equivalence to the original drug in clinic trials. The firm points out that the OGD's new stance is that dissolution tests are sufficient measures of equivalence for approval. At a time when the government and the media are highlighting the need for increased vigilance in treating serious infections, they believe that OGD may have underestimated the rigor needed to guarantee a truly equivalent generic version of Vancocin. While they do not expect an immediate resolution, they doubt that the new OGD stance will stick. If the OGD reverts to its original guidance, they believe Vancocin will enjoy exclusivity until at least 2010.

This rating information was reported by JMP Securities.

[ast191]

hello

[upndown1313]

Ideal, the solubility is cleary listed in the Merck index. Doesn't make me comfratable that Will doesn't know this. If Akorn is pushing, they will initiate discussions quickly. However, there is no idication that Akorn has engaged FDA as of yet. If not they will take their time I think. I do not know the procedures surrouding the stay that VPHM has asked for but I will try ot find out.

Oinchat, the COR board is Yahoo board for Cortex.

[oinchats]

What is the COR board?

[oinchats]

Since 49 million shares were sold and bought there had to be institutions buying also as this could not have been retailers buying. So I think the % of institutions holding is still high.

[ideal_1000]

Thanks for the work net, is there a monitor here?

[ideal_1000]

Thanks for the analysis updown. I'm not disputing what you are saying, but I could have sworn that Will told me that Vancocin was not water soluble (that was his basis on saying that there would need to be clinical trials). That is why I stated that on the COR board.

updown, how soon could we hear about the FDA deciding to initiate open hearings?

[warlord]

Tom thanks for your response. I guess I wish that I had sold some too as I have over 56000 shares and last week was a bloodbath. Do you have an opinion on how low this could go based on TA?
Dick

[tom14100]

There has to be demand for the price to move up and as of Friday VPHM was treated as though it were a leper. I can not imagine institutions buying unless they either 1) felt sure the FDA thing would be resolved favorably or 2) felt sure Marivibar results would be good. After the carnage last week, I rather doubt if there are enough of us little guys with enough money to move it up much either. Do not forget though, that the institutions almost always learn about these things before they are announced and act accordingly. That is why TA works so well, for example, high volume usually reflects institutional buying or selling before the reason behind it is known..... If the price moves up on low volume, be wary. I suppose there might be some insitutions willing to buy where it is now without knowing for sure the outcome, but in good prudence I wouldn't think too many would.
I'm not trying to be negative, just realistic. I had 20,000 shares and sold off 13,000 around $20, so I still took a bath last week and would like to buy back in because I believe the potential is enormous, but I want to see the demand come back before I put more money on the table.

[warlord]

Tom, I'm not too experienced at trading but have a lot of shares in VPHM. I was curious though, Is there a possibility of the institutions either bying back in sooner or others picking up shares if the share price does increase quickly. Does the stock price increase have any effect or will they still wait to get a result with the FDA? Is there a chance that new institutions will take a position at this price?

[upndown1313]

Impact of Generic
The key issues are FDA requirements and timing.

Vancomycin is a highly water soluble drug with poor GI membrane permeability. Generics can request a biowaiver for BCS1 drugs (Biopharmaceutucal Class System 1) based on high solubilty, high permeability. Vancomycin is high solubility/poor permeabilty drug and would normally require a biostudy in order to get FDA approval. Since the drug is not absorbed systemically, the only way to show true bioeqivelence is with a clinical efficay study. I suspect VPHM will submit data to the FDA to show that the formulation is important in efficacy. If this is the case, I would expect FDA to sponsor open hearings on the subject. This could take months for the FDA to decide.
If FDA delays decision on this, expect rapid recovery of pps.

[tom14100]

Despite the fact that this selloff was grossly overdone and the stock is at firesale prices, I do not anticipate any kind of substantial bounce back (and as your friend stated, a bit more drop is certainly possible). I am very thankful that this happened on Friday so there was some time to cool off. I think that will help considerably with stabilizing this as more rational minds can assess the situation. That said, there were clearly a lot of institutions selling Thurs-Fri and I seriously doubt if we see them jumping right back on the wagon until the FDA issue is put to rest. I actually think it's going to take a combination of the FDA issue being put to rest in our favor + good results on Maribivar before we make serious tracks North. This may take a month or two and actually I hope this is the case because I would like to see a decent base build that we can launch forward from as progress is made on the fundaemental front. I will feel better about buying more after a base is built, than I would if this just starts moving up again without any resolution of these issues.

[Emptyhead]

Come on guys! Go out on a limb and take a stance. VPHM is undervalued!

[zacko1223]

I called a good buddy of mine Friday evening, he's been a fund manager for approx 16 years and is quite good with TA. He very much likes $9.80 as the absolute bottom and expects the stock to bounce hard, if it reaches to that point. I discussed with him regarding the gap which was filled from last August (I believe....10.28?)...he states that although it is technically positive that the gap was filled, its not always necessary that all gaps get filled...look at google, its been gapping up since $100....and most of those gaps probably will never get filled.

He also did some more DD on the stock and still does not see a legitimate reason for the sell-off?...he points more to a combination of built up fears regarding this generic replacement, with the downgrade which came out thursday through infineon. Unfortunately its like anything in life...when dirty rumors spread, especially through wallstreet..it gives people the itchy finger to sell....and combine that with all the electronic stop orders and theres your 5 point drop. He is in shock the stock is running a PE of 5. He basically stated that it would be absolutely stupid to unload shares at this point as the worst has already happened. He loves the stock at these prices, and might buy some this week for his own personal account.

My personal opinion is that since last November we have been stuck in this tight trading range, thanks to poor management decisions and a lack of PR. Maybe this sell-off was what we needed to get management to wake up and step up to the table. Once this is cleared up, there is no reason why we cant see 30+ by years end...JMHO

[nocheintyp]

Q about link and What'll be monday's action

(first 8 words are the title of this message - let's see)

brian, tom,

did the link work that I gave in the email?

It would be nice to have irc, kudzu, laserman, ... here also, but I don't want to give the link to this board on the Y! board. It then could easily happen that all the bashers/pumpers over there simply move to here.

I am still in 3 posts per day mode, I don't have any idea up to now how I can change this. It would be good to know.

So I have to stay collected

The crucial question for monday is, will VPHM tank even more or have we seen the bottom yet?

In my opinion the evaluates to the question: Was the sell-off based on the generic story alone or have Maribavir (I hate to say it: bad) news leaked to the tutes?

Maribavir news are crucial for the future p/e in my opinion, VPHM has to show that they are able to develop a drug on their own (I at least want to be listed in the biotech index, not in the wholesaler index if there is such thing).

If Mari pr will be good, then two years (or so) less of Vanco sales on NON GENERIC PRICE LEVELS (it will still sell after the generic would be out) wouldn't effect the pps too much, hopefully. Of course, a good HCV-796 pr would do also (maybe not that much, who knows)...

Another question: How should a sudden and substantial price increase of Vanco be interpreted? Now this is not only a bad pr-concern, but could also be interpreted as a sign of capitulation (if one wants to think the worst case scenario).

Well, I will stick to my shares at least until Mari news are out. What are other longs opinions on buying/holding/selling?

GLTL, net

[stevecapitolhill]

Thanks for getting us here NET. Looking forward to a more reasonable discussion without all the yelling, flaming, etc.

[brian_06355]

Hi everyone. This board looks much better.

Brian

[tom14100]

Does anyone have any insight into the FDA and whether or not the generic process is realisticly going to be shortened. It seems incredible to me that the FDA could just out of the blue change the rules of the game so dramatically.

[nocheintyp]

Hello to the board. I will post this site to the collected longs from the Y! board as soon as possible (still busy).

Hope this one will prove as more stable to overcrowded situation.

GLTL, net

[upndown1313]

Glad there is an alternive message board. Very Difficult to make any sense of the yahoo board since the Friday massacre.

[pnnymn]

Cramer wore a post-it note with ViroPharma's (VPHM:Nasdaq - commentary - research - Cramer's Take) ticker on his forehead, admitting that he his earlier bullish call was wrong.

[pnnymn]

Yes. I was trying to quote what Cramer had said 3 weeks ago. Old news now.

[goldmining05]

30-40 stock! Try $10 OUCH!

[Bobwins]

I'm typically not in favor of Cramer liking a stock I like. His followers are hit and run and don't always know why they are buying the stock. They are just reacting to his show and buying. Some traders take advantage of his bullish calls to day trade any impact his viewers might have.

This increases volume but the effect is typically short lived and I am not convinced the daytraders help.

Bobwins

[pnnymn]

Cramer all over it today. long vphm. 30-40 dollar stock.

[mugur]

Forbes analysts say BUY


http://forbes.marketedge.com/Secop/VPHM.asp?refer=forbes

[mugur]

For Yahoo board members:WELCOME
THis is a moderated board and people with agendas will NOT be tolerated and REMOVED.
Enjoy a NICE VPHM board