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To: Jibacoa who wrote (673)3/9/2007 10:00:35 AM
From: zeta1961Read Replies (1) | Respond to of 802
 
CC..I'm glad I opted for going to the beach..nothing earth shattering in the CC..Nance mentioned the short sellers raiding the newswires..and they addressed some of the blogger's/Feuerstein's criticism without mentioning names(so to speak)..ie..they stressed that the p53 biomarker data from P2 tumors that they released last Q was obtained in a blinded fashion..the P3 statistical plan using the biomarkers(which includes clinicals like response)was agreed upon with the FDA and they made an "IND amendment" versus getting an SPA..which they said would have taken longer to get the SPA than the former..this was a sticking point for the bloggers as indeed, in prior years, their 10Q's did indicate they had an SPA....I'm personally glad they didn't have one because it's much harder/almost impossible to amend an SPA..one of it's disadvantages..

They stressed strongly(Nance, Sobol, Talbott)that yes, the BLA will be filed by EOY..

They did talk about "adaptive clinical trial" where essentially, P1 and P2 data is scoured to find out as much as possible about the molecule(dosage, route, biomarkers, target population) when discussing all their work re: Advexin, Mda7 and the rest of the portfolio.....and this imho, is what the bloggers due diligence failed..since it's relatively new and is part of the Critical Path initiative(Wyeth, MD Anderson are 2 currently in the early phases of using it)...from what I'm reading this week, the P1/P2 phase necessarily takes longer but if done right, reduces P3 failure..when the bloggers made fun of Nance for in the past saying: "P1-P3's will be blurred," he was speaking using the model of this 'adaptive mode."...this link, on the bottom of page 3 says this verbatim pharmexec.com

For sure, he should have been explicit about this in the past.

They're designing a Mda7/Avastin which will be adaptive..

Obviously, it's up to INGN to meet guidance for their BLA submission by EOY since nobody on the call cared about the rest of the pipe until they do this..

Interestingly, someone from a cancer advocacy organization asked them about Gendicine and whether the FDA would use Sibiono's data and if INGN would work with them..Nance essentially said no to both..



To: Jibacoa who wrote (673)3/9/2007 10:42:49 AM
From: zeta1961Read Replies (1) | Respond to of 802
 
Please pass the Advexin lotion.. Suntanning is regulated by p53..this is in the headlines today..here's the abstract:

Central Role of p53 in the Suntan Response and Pathologic Hyperpigmentation

Rutao Cui,1,2 Hans R. Widlund,1,2 Erez Feige,1,2 Jennifer Y. Lin,1,2 Dara L. Wilensky,1,2 Viven E. Igras,1,2 John D'Orazio,1,2,6 Claire Y. Fung,3 Carl F. Schanbacher,4 Scott R. Granter,1,5 and David E. Fisher1,2,

1 Melanoma Program in Medical Oncology, Dana-Farber Cancer Institute, Harvard Medical School, 44 Binney Street, Boston, MA 02115, USA
2 Department of Pediatric Hematology/Oncology, Dana-Farber Cancer Institute, Children's Hospital Boston, Harvard Medical School, 44 Binney Street, Boston, MA 02115, USA
3 Department of Radiation Oncology, Massachusetts General Hospital, Harvard Medical School, Fruit Street, Boston, MA 02114, USA
4 Department of Dermatology, Brigham and Women's Hospital, Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA 02115, USA
5 Department of Pathology, Brigham and Women's Hospital, Harvard Medical School, Boston, MA 02115, USA

Corresponding author
David E. Fisher
david_fisher@dfci.harvard.edu

Summary

UV-induced pigmentation (suntanning) requires induction of a-melanocyte-stimulating hormone (a-MSH) secretion by keratinocytes. a-MSH and other bioactive peptides are cleavage products of pro-opiomelanocortin (POMC). Here we provide biochemical and genetic evidence demonstrating that UV induction of POMC/MSH in skin is directly controlled by p53. Whereas p53 potently stimulates the POMC promoter in response to UV, the absence of p53, as in knockout mice, is associated with absence of the UV-tanning response. The same pathway produces ß-endorphin, another POMC derivative, which potentially contributes to sun-seeking behaviors. Furthermore, several instances of UV-independent pathologic pigmentation are shown to involve p53 “mimicking” the tanning response. p53 thus functions as a sensor/effector for UV pigmentation, which is a nearly constant environmental exposure. Moreover, this pathway is activated in numerous conditions of pathologic pigmentation and thus mimics the tanning response.

cell.com



To: Jibacoa who wrote (673)3/14/2007 11:49:25 AM
From: zeta1961Read Replies (1) | Respond to of 802
 
INGN made it in the Contrarian Shopping List over at Motley Fool..dang, I was one of those panic sellers!..dow giving back its ytd gains had a big impact on my decision too..

fool.com

The Contrarian Shopping List
By Rich Smith
March 13, 2007

"We simply attempt to be fearful when others are greedy and to be greedy only when others are fearful." -- Warren Buffett

Out of the quadrillions of quotations quarried from that most loquacious of quotationists, this one holds a special place in Foolish investors' hearts. Are you looking to "buy low" so as to later "sell high?" If so, your best chance of getting that initial low entry price comes when panicked sellers are unloading their shares at whatever price is on offer.