Everyone should take a look at this from Delcath yesterday
8K filed yesterday.
Go to google and type in sec gov and click on first site. Then at the right top; type in Delcath. Click on the first Delcath. Then click on the second one; which will say Exhibit.99-1 and take a look at this.
Very Brief Summary:
2013: $2-3 Billion Dollar Opportunity
Chemosaturation: Allows for over 100x normal treatment, treats the entire liver...not just pieces like CLSN, Controls system toxicities, proven to improve liver disease.
PUDUFA DATE: June 15, 2013
**It will be approved**
Delcath to discuss expanding the uses of Chemosat in HCC, NET, and CRC. 3 FDA meetings scheduled.
Advisory Committee in May 2013.
Orphan status by FDA means 7 Years of Exclusivity.
6 US patents and 6 more pending plus 5 years patent extensions Post FDA approval.
Trade secret protection of GEN II filter.
CASH: Around 21 Million
CASH BURN RATE per Q: @ $10 Million
$20 Million Line of Credit
87.2 Million Fully Diluted Shares as of DEC 31, 2012
Very Experienced Management Team with Decades of Experience.
Secured Agreements with 14 Leading Cancer Centers in EU.
Reimbursement Agreements being accomplished at a Rapid Rate
One of the main goals; besides FDA approval is a Partnership in China. CLSN's loss is DCTH's gain.
100 x the chemo drug Melphalan at the site of the Tumor.
Gen II filter keeps the chemo out of the main blood supply.
Delcath has accomplished a lot in 2012 and plans on accomplishing even more in 2013. Now is the time to get in to this one; especially prior to May advisory committee meeting and then the June 15th date with the FDA on approval.
This really should be approved. If it is approved Delcath will then look at other metastic cancers and possibly other agents for treatment.
Decath can control this market for years and years to come and they have accomplished all of this in spite of CRL from FDA and having less than 100 million shares outstanding.
I applaud the entire team at Delcath. They are very strategic and there has never been a better time to invest in this company.
I see the market cap approaching 800 million at least this year! Do the math on the stock price appreciation.
I wish I was paid for pumping this; it would be my pleasure.
Look at it this way, this helps cancer patients with liver cancer. I do not understand why the FDA is so picky about not allowing it be approved for other liver cancers instead of ocular liver cancer mets.
I am not a so called pumper. I was in this stock a couple years ago prior to the FDA requesting more data. I just haven't posted much and it's been very bleak for most investors. I am trying to communicate that Daylight may be just around the corner.
This is a good company, this is not a scam, like that Idiotic PharmaHero "Short Seller" says, he plays the Devils Advocate; but this company has a handful of very bright people that will lead this company in the right direction. The #1 focus right now is just to be approved in the United States.
If you read the latest 8-K it has their strategies for marketing in the US planned and ready to go immediately, but they need that all important Yes from the FDA.
The other major chemo agent is Doxyrubicin; which they will go for next in Multiple Liver Cancers. Why they cannot do this right now; just says that the FDA was in a crazy state of mind. At the time I think they were frightened of this device as they were afraid that it would kill people.
Don't most of you believe that it is already pretty clear that Doxyrubicin and Melphalan works with Multiple Cancers??? I know it does, because I have studies both of them and their uses...I just don't understand why the FDA desires studies for each type of liver cancer, just dumb in my opinion.
I think you will see Delcath work with a major pharmaceutical company in China, if not a pharma, some of the major cancer centers. Just like Celsion had the deal with Hisun....one of the makers of Doxyrubicin, Delcath needs to figure out a strategic path to enter China, because that is where a large percentage of liver cancer occurs.
There's good money to be made for all involved, with all the reimbursement news.