DNDN 10 Days away from FDA approval

I

Informed

What can you see from the schedule?


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CONGRESS DAY 4 – 22nd April - STREAM 2 – CANCER IMMUNOTHERAPIES: REDEFINING A MARKET
09.00
Chairman’s opening remarks
Dr Jeffrey Schlom,
Chief, Laboratory of Tumor Immunology and Biology, Center for Cancer Research, NCI, Vaccine Research Center / NIAID / NIH
09.05
Critical endpoints and response criteria for cancer vaccine clinical trial design

* Identifying endpoints and types of approvals and providing clinical evidence of effectiveness
* Why Phase III trials fail / novel Phase II trial designs to avoid a Phase III trial failure. Learning from the past
* Avoiding clinical hold and landmines in cancer vaccine development. Progressing through FDA

Dr Bindu George,
Medical Review Officer, Office of Cellular, Tissue and Gene Therapy, CBER, US Food and Drug Administration


09.30
Pivotal Phase III IMPACT study results in advanced prostate cancer

* Pivotal Phase 3 IMPACT study of PROVENGE® (sipuleucel-T) meeting its primary endpoint of significantly improving overall survival compared to placebo
* IMPACT results confirming further potential for active cellular immunotherapy candidates
* Meeting criteria and specifications in its SPA agreement and amendments to its existing Biologic License Application to advance through regulatory process and seek licensure
 
DNDN will sell off on the news, if not worse. I say this after having made a huge amount on holding DNDN from 23 to 36 recently. Save my butt, in fact.


But this is a sell the news event. There might, and i mean only maybe, be a spike on the initial approval, but it will be short lived.


The truth is everyone knows approval is almost guaranteed, and the big hedge fund investors will sell into the excitement. ONce approval is finished they will have a long slog to show actual revenues & profits.


Personally, i think DNDN is an exciting company, but this is a time to get ready to take profits, not buy in on an "approval pop". Its just not that easy...
 
Hedge funds only have ~5 million shares, too little for next Apple or DNA.

Announcement of approval during this meeting would be huge positive news.

Next: Partner and new indications.

BTW, everyone is waiting for Apple sell off tomorrow.
 
I also have DNDN from about 25 and still hold onto it. I'm getting pretty fricking nervous. I was going to write calls when it hit 40. I still might do something along those lines to protect my profits, I'm getting too nervous that the approval is a bit too obvious.
 
Quote from jedwards:

I also have DNDN from about 25 and still hold onto it. I'm getting pretty fricking nervous. I was going to write calls when it hit 40. I still might do something along those lines to protect my profits, I'm getting too nervous that the approval is a bit too obvious.
More...
same here, looking to write atm calls just before the announcement.
 
The MM is setting to run up the stock slowly toward 45 till May 1, but tomorrow's meeting might screw their plan, I imagine tomorrow meeting might run like this:

-----------------------------------------------------------------
@9:00 FDA presents how to set up end point (excuse for delaying 3 years)

@9:30 When DNDN CMO on the stage, the Chairman and FDA comes back to announce FDA has just approved...
------------------------------------------------------------------

@9:00 DNDN halted pending FDA announcement
@9:30 news hits the wire DNDN received FDA approval
@10:00 DNDN conference,
@11:00 resume trading $50
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(I personally prefer no announcement tomorrow, but who knows)
 
http://www.terrapinn.com/2010/wvcdc/Programme_5067.stm

CONGRESS DAY 4 – 22nd April - STREAM 2 – CANCER IMMUNOTHERAPIES: REDEFINING A MARKET
09.00
Chairman’s opening remarks
Dr Jeffrey Schlom,
Chief, Laboratory of Tumor Immunology and Biology, Center for Cancer Research, NCI, Vaccine Research Center / NIAID / NIH
09.05
Critical endpoints and response criteria for cancer vaccine clinical trial design

* Identifying endpoints and types of approvals and providing clinical evidence of effectiveness
* Why Phase III trials fail / novel Phase II trial designs to avoid a Phase III trial failure. Learning from the past
* Avoiding clinical hold and landmines in cancer vaccine development. Progressing through FDA

Dr Bindu George,
Medical Review Officer, Office of Cellular, Tissue and Gene Therapy, CBER, US Food and Drug Administration
09.30
Pivotal Phase III IMPACT study results in advanced prostate cancer

* Pivotal Phase 3 IMPACT study of PROVENGE® (sipuleucel-T) meeting its primary endpoint of significantly improving overall survival compared to placebo
* IMPACT results confirming further potential for active cellular immunotherapy candidates
* Meeting criteria and specifications in its SPA agreement and amendments to its existing Biologic License Application to advance through regulatory process and seek licensure

Dr Mark Frohlich,
Chief Medical Officer, Dendreon Corporation
 
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