Sounds smart to me Trader!  The data isn't in until October- this can make several runs up or down at different paces in the interim space!  Maybe you will end up trading it 3-4 times or just once?

 

At least its going in the right direction generally!

 

Kutz 

Consider it trade 1 of 3 heading into October!  Profit is good!

 

kutz 

 

now J+J got whacked even though again the drug is approved in the EU-soon you will have to go across the pond to get treatment!

 

This is why it is becoming almost foolish to play FDA decisions on drugs. You used to have fighting chance (risk vs big gain) Now:  They convene advisory committees and instead of following the supposed expert testimony, they use it to provide political cover, ignore them, and reject anyway. They then hide behind proprietary concerns that unapproved drugs have for their companies and as an investor you can't fairly calculate the odds for success/failure. They aren't evaluating the science and the drugs capability-they are evaluating their process on how to ensure their butts are covered!  Easy to see "if I approve little or nothing and create road blocks, I then can not be attacked later.  its an acceptance of what this process is-not ever for sure and risk vs benefit.   They take risk out of the equation and patients miss any benefit!

 

I don't want bad drugs on the market but the pattern is clear  This stymies the entire biotech world in the US.  Bushes FDA leadership must be purged or they will destroy one good industry America has left!  This agency track record is like every other federal agency now-dismal.  This is what happens when the leadership in each agency is only beholden to its ultimate leader and not to actually doing a job.

 

Invest in drug mergers, buyouts, data reporting etc, but investing in FDA drug decisions is torture currently-don't do it unless you are married to the particular stock!  I can't barely figure it out and I have been doing it for 10 years.

 

JMO

 

Kutz 

DNDN drop in synch (smaller) to drop to CEGE because the are both immunotherapies.  DNDN is specific to the patient.  This is why blood is drawn sent to DNDN, drug concocted and mixed, and then sent back to patient for infusion back.

 

CEGE immunotherapy is like a cocktail and less specific to the specific patient.  Try to stimulate the immune system more globally (multiple pathways).

 

Hard to tell what DNDN will do in this space where CEGE tries to figure out what happened! 

 

Kutz 

Trader:  Nope-look for it in mid October-you have about a month.

 

Kutz 

Its getting closer!

 

 

CEO gold presenting at meetings-a buildup into the data should start soon!  Two to 4 weeks tops I surmise.

 

Kutz 

Bruno-you watching this meat the last two days?  Got to think this is the REG SHO thing.  They have been on it for so long they were the poster child for phantom shares!  The data reporting inching closer doesn't hurt the situation.

 

Kutz 

Selling half on the news,  what about you Kutz

Bruno:  You were gone for a while-hurricane!

 

I sold half a couple weeks ago (reported in the general dow thread) and the rest this morning.  extreme trouble getting on the board-this may not go through?

 

The results showed 20% survival and the success of the study needed to be a 22% increase in survival.  This means the interim data were good, but did not meet the statistical threshold for approval off the interim data that was previously posted as the agreed to goal between FDA and DNDN.

 

Therefore I believe the study will go to its conclusion in 2009 and I have severe doubts the FDA will approve this based on the current results.  DNDN can submit and try, but based on what happened last year, I doubt they will let this through.

 

You can hold and hope the FDA says good enough?  They don't have a history of doing that based on the powerful dude in the FDA oncology division (Dr. Pazdur).  If the FDA were working properly they WOULD let this through!

 

Its a very risky bet upon release of these survival data.  I recommend listening to the DNDN 9:00AM presentation hosted by Dr. Gold (DNDN CEO) this morning.

 

I am out for now (better or worse)

 

JMO

 

Kutz 

CNBC Mike Huckman interviewed with CEO of DNDN at the big biotech conferencewas just completed-study progresses.  The last 2% survival is within reach for later in the year. 

 

Says he is on the 10 yard line and needs to punch it in-I hate those sport analogies for bio drug development.  The last dude to use those analogies was the CEO of ENCY.  The company doesn't exist anymore.  I believe DNDN will dance with the FDA later this year once again.  One can hope it will be as crazy?

 

The time will come to jump this again-not yet!  This board will be gone.

 

Kutz