mikehav

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Updated FDA Decision Calendar: Five Decisions Before Year-End

Ulysses Benjamin Dover, I guess we will found out by the end of April if your analysis is also faulty

If you were long going into the BLA filing/acceptance you already made a lot of money - I have no position long or short in the past and no plans for a position either way in the future - only watch NFLD as part of my FDA calendar of pending new drug decisions

On Jan 05 11:14 AM Ulysses Benjamin Dover wrote:

> Mikey, once again your analysis is faulty. Like Feuerstein you miss
> the central issue of what Polyheme is. It is NOT supposed to be a
> substitute for blood when blood is available (not this version anyway,
> butt someday), it is for when somebody is bleeding out and there
> is no blood available. There is a substantial need for such a product,
> hence why the FDA walked this product through a controversial clinical
> trial and now has granted fast track. To boot, the military wants
> this product.
>
> The important data is NOT a direct comparison of how Polyheme compares
> to blood as a substitute for blood, but how close to being like blood
> for when there is a need for blood but no blood is available. In
> the prior study it was found that people who were going to die from
> bleeding out, had about a 70% survival rate with minimal adverse
> events v. getting saline. It really is simple deductive reasoning
> that if I am going to die from bleeding out because we can't get
> me a transfusion in short order and am offered a 70% chance at survival
> using Polyheme, I'm using the Polyheme.
>
> This product will receive a limited approval, the stock will rise
> and the company will be bought by a large well funded company that
> can develop and market the product further. Of course, part of that
> deal will be Dr. Gould to get a great paying job, but that's fine,
> we'll see a price north of $6 (extrapolate near term profit potential
> just on U.S. remote location trauma usage) in 2009.
Jan 06 04:55 am |Rating: 0 0 |Link to Comment |View article
139 Names on ETF Deathwatch

AirShares (ASO) Carbon Fund seems destined for the list even though it just started trading 12/15/08:
www.etfinnovators.com/...

iPath Global Carbon ETN (GRN) has been trading about six months now with little in the way of net assets or trading volume and I see it made the list
Jan 04 19:40 pm |Rating: 0 0 |Link to Comment |View article
Affymetrix Remains a Value Trap Until Its Results Improve

AFFX should do well at least early in 2009 since it is a small-cap that got crushed in 2008, although it has already rebounded by over 50% from the low around 2 bucks and used about half of its net cash to buy Panomics. Don't think I would hold it going into the next earnings release as lately they have missed estimates and lowered guidance. If the market sustains recent positive momentum, you can buy about anything and make money -- especially the small, high beta names that got beaten up last year. I haven't bought any AFFX since there is no near-term catalyst expected, although the huge cash position means they will be around long-term and could get acquired at some point.
Jan 02 18:15 pm |Rating: 0 0 |Link to Comment |View article
Updated FDA Decision Calendar: Five Decisions Before Year-End

I agree with Adam Feuerstein's analysis of NFLD's Phase 3 trial for PolyHeme below:
www.thestreet.com/stor...

Also, the death rate for PolyHeme was 37.5% higher than the control arm in the Phase 3 trial when all 712 patients are analyzed and 18.7% higher when the 126 protocol violators are removed, which is in-line with the numbers reported in the JAMA meta analysis

712 patients: 349 got PolyHeme, 363 standard of care --> 46 patients died from PolyHeme arm (13.2% rate) vs. 35 died in control arm (9.6% rate) missed statistical gaol of non-inferiority

Excluding 126 protocol violators (18% of the patients in the study) --> leaves 586 patients to analyze resulting in 10.8% death rate for PolyHeme vs. 9.1% in control arm, which results in achieving the non-inferiority goal for statistical analysis for PolyHeme

Among the 126 pateients excluded for protocol violations --> 23% death rate for PolyHeme (17/70) vs. 12.5% for control arm (7/56)

NFLD got a nice pop on acceptance + priority review yesterday so you were right to be long. However, the FDA typically prefers intent to treat analysis which better reflects real world conditions, especially in the case of emergency medical treatment such as the PolyHeme trial so I don't think they will accept the exclusion of 126 protocol violators to achieve non-inferiority.

I have not traded or invested in NFLD long or short, but it looks like most people are taking their profits today with the stock down about 20% at this point. Finally, I hope that a safe blood substitute can be developed at some point to address the needs you outlined, but I don't think PolyHeme is the answer.

Dec 31 11:48 am |Rating: 0 -1 |Link to Comment |View article
New Scandinavian Nordic Region Index

PowerShares (PWD) FTSE RAFI Europe Small-Mid Portfolio

www.invescopowershares...

On Dec 18 09:25 AM aitvaras wrote:

> Is there any ETF available which includes the Baltic states, especially
> Latvia?
Dec 18 09:55 am |Rating: 0 0 |Link to Comment |View article
First-Ever Airlines ETF Set for Takeoff

A Short ETF for the airlines may have been a better idea:
www.etfinnovators.com/...

On Dec 11 07:25 PM k9s-4-k8 wrote:

> Talkin' bout an ETF that's prone to crash and burn!
>
> Sorry I couldn't help myself.
Dec 11 20:51 pm |Rating: +1 0 |Link to Comment |View article
Looking for Laggards After the Latest Market Rally

Here is the rest of the article from my blog with a valuation comparison of HITK vs. CPD:

With shares of HITK trading up today by about 25% on record quarterly revenue of $25.1M and diluted net income of $1.1M or 9 cents per share, Caraco appears extremely undervalued at current levels of $3.50 per share. Caraco trades at the lowest price to sales ratio [PSR] in the generic drug industry at just 0.24X with a trailing price to earnings ratio [PE] of less than 4X, zero debt, $33.6M cash, and a market cap of $123M. As a comparison HITK trades at a PSR of 0.84X with an estimated forward PE of 16X, negligible debt, $16.1M cash, and a market cap of $71M.
Dec 09 18:11 pm |Rating: 0 0 |Link to Comment |View article
New Index of Pet and Animal Care Companies

At least one expert in the ETF industry would disagree with you:
www.etftrends.com/2008...

Also, there are favorable growth trends in the animal & pet care industry and the potential for buyouts of the smaller companies by big pharma companies with animal health divisions such as SGP & PFE, but I am sure you know all of this based on the extensive research required for such a comment -- "is it just me or does this seem a bit ridiculous" --

Domestically, pet spending for 2008 is estimated to be about $43.4 billion, up from $23 billion in 1998.

The worldwide market for animal healthcare, excluding bulk feed and nutrition products, is expected to reach just under $20 billion in 2008, experiencing growth of 26% from a level of $15.6 billion in 2003.
Dec 06 09:45 am |Rating: 0 0 |Link to Comment |View article
Lumber Prices YTD vs. Timber ETFs

Here is a link to 3 recent articles comparing the global price of coal futures to the 2 coal ETFs (KOL + PKOL) and other energy commodity funds:

www.etfinnovators.com/...

On Nov 25 12:54 PM sbenard wrote:

> I had been wondering how closely correlated the futures would be
> to the ETFs. Thanks for the info! I've noticed that commodity futures
> also tend to be somewhat less correlated to commodity stocks, following
> this same pattern.
Nov 25 14:42 pm |Rating: 0 0 |Link to Comment |View article
73 Decision Dates on Updated FDA Calendar

But since those examples are history --> Look for major upcoming decisions for small/mid-caps CYPB, PTIE, KG, ALO to name a few that will have major stock price impact

On Nov 24 05:23 AM mikehav wrote:

> How about 50% gain or LGND, 103% gain for AMAG, 80% decline for TARG
> witihin the last few weeks based on either approval decisions or
> panel recommendations
Nov 24 05:31 am |Rating: 0 0 |Link to Comment |View article
73 Decision Dates on Updated FDA Calendar

How about 50% gain or LGND, 103% gain for AMAG, 80% decline for TARG witihin the last few weeks based on either approval decisions or panel recommendations

On Nov 23 09:59 AM BlueOkie wrote:

> Nice to know information but not sure how it relates to investment
> decisions. Unless a new drug will cause a big move in stock price,
> it has only small value.
Nov 24 05:23 am |Rating: 0 0 |Link to Comment |View article
New Emerging Biotech and Pharma Company Index

Below is link to my original blog post where you can click on the image to enlarge or download:
www.etfinnovators.com/...
Nov 23 10:17 am |Rating: 0 0 |Link to Comment |View article
Defensive Dividend Stocks Offering Value Now, And Comparative ETFs

Try the original post at my blog - click on the image to enlarge and it is easy to view or download:
www.etfinnovators.com/...

On Nov 19 08:28 AM anonNH wrote:

> chart is lo res & unreadable....
Nov 19 09:05 am |Rating: 0 0 |Link to Comment |View article
10 Micro and Small Cap Healthcare Value Stocks Currently Under the Radar

Here is the other part of the article (ex-healthcare):
Industrials – Textile Manufacturing: Culp (CFI) trades at some of the deepest valuations of all the companies listed with a PSR of 0.15X, PE of 7X, and a PBR of 0.4X and I wrote about it recently as a turnaround candidate on cost cutting and debt reduction despite its exposure to the highly competitive furniture and bedding markets as a manufacturer of upholstery and mattress fabrics in the face of housing and economic downturn.

Industrials – Security Products/Services: Napco Security Systems (NSSC) has lost over two-thirds of its market value in the past year as a provider of electronic security products that has been affected by the housing and economic slowdown. However, Napco has been in the business for over 30 years and the Founder & CEO, Dick Soloway, owns about 6M of thhe19M shares of outstanding common stock.

The Company is conservatively managed with a history of accretive acquisitions and has the ability to navigate through tough economic conditions. Also, a commitment of over 5% of revenue to R&D for the development of innovative products positions the Company well for enhanced profits once th economy and housing markets rebound. Click here for my September 2007 article on Napco and some peer valuations, including 2001 acquisitions by Tyco (TYC) at about 2X sales for Sensormatic and SecurityLink – a full 4X greater than Napco's 0.5X PSR.

Industrials – Infrastructure: L.B. Foster (FSTR) is a manufacturer of products for the railroad, construction, energy and utility markets which is poised to gain on prospects for increased spending by the government to improve our nation's infrastructure.

Alternative Energy – Solar: Canadian Solar (CSIQ) has traded down sharply on lowered estimates and analyst downgrades, which appear to be piling on the stock at or near the bottom as it has cratered from all-time highs of around 50 bucks to a low of 5 bucks this week.

Technology – Alvarion (ALVR) provides WiMAX and other wireless broadband connectivity systems worldwide which trades at an EV of just $55M despite being profitable with excellent growth prospects. CIBER (CBR) is an IT services company trading at 1995 levels on lower profit and sales guidance for 2008.
Nov 16 05:09 am |Rating: 0 0 |Link to Comment |View article
Updated FDA Decision Date Calendar

No FDA sites or free websites that I know of - that is why I maintain the list at my blog and post here at Seeking Alpha with updates:
ETFinnovators.com
Nov 14 08:59 am |Rating: 0 0 |Link to Comment |View article

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