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Biotech / Medical : Ligand (LGND) Breakout! -- Ignore unavailable to you. Want to Upgrade?


To: RXGOLF who wrote (17952)3/26/1998 9:40:00 PM
From: Henry Niman  Read Replies (1) | Respond to of 32384
 
I suspect that the FDA figured that they want the most current data and since the trial was completed, they wanted LGND to do the analysis and include the final (instead of interim) data in the filing. Since the Bear Stearns' report already hinted at at 2Q filing, I suspect that the delay isn't that new to institutions, which may be why they are on the sidelines.

It is LGND's first NDA and it's always hard to nail down exactly what the FDA wants, but it certainly looks like LGND will deliver the goods and they may be able to trade off a more robust filing for a quicker review.



To: RXGOLF who wrote (17952)3/26/1998 9:44:00 PM
From: Machaon  Read Replies (4) | Respond to of 32384
 
Interesting points from the Panretin gel article:

<====================================================================
" ... we have decided to take an additional six to eight weeks to file our NDA on Panretin gel for KS. ... may also simplify or shorten the review time by the agency, helping to minimize time to market,"
====================================================================>

So..... on the one hand, a delay. On the other hand, perhaps a faster approval?! I wonder if the Market will consider this more on the positive side? Is the glass half full, or half empty?

<===================================================================
Results of the Phase III North American trial ... demonstrated that 35.1 percent (47 of 134) ... experienced complete or partial response.

Patients in the Panretin gel group had the option of continuing treatment ... The response rate (complete and partial response) was 49 percent (66 of 134)

====================================================================>

Damn, that stuff is good! It blows my mind to think that skin cancer can be treated with a gel!

I wonder how Panretin stacks up against the other forms of skin cancer?

Well...... not meaning to hype this stock, but.......

GO LGND!!!

Regards, and good luck, Bob



To: RXGOLF who wrote (17952)3/26/1998 9:50:00 PM
From: John O'Neill  Read Replies (2) | Respond to of 32384
 
What is IND vs NDA? this may sound dumb, but l what are threads for if not to air basic questions.

JO