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


To: Mudcat who wrote (28971)6/25/1999 9:45:00 PM
From: Henry Niman  Read Replies (2) | Respond to of 32384
 
Speaking of confusion, did you ever come up with the Ligand document that indicated Targretin Oral would be filed in 4Q '98?

I believe that you will be hard pressed to find such a document. As I referenced yesterday, last summer I asked LGND IR about a filing date and was told that they were shooting for the end of '98 / beginning of '99 and they didn't know if the filing would be for oral or topical Targretin.

I think that the 4Q deadline is an optimistic guess by IR and a figment of your imagination.

I went back to analysts reports and came up with one by BBRS in late Aug, 1998.

They did mention the PANRETIN approval in 4Q, but there was no mention of a TARGRETIN filing in 4Q '98 or 1Q '99, although they did mention anticipated filings by others in that time frame (bold added):

FDA Product Approvals Expected By Year End
Company – Product/Indication
BioChem (BCHE $15-1/2) expected to receive approval of lamivudine in United States and other countries by year end
Genentech (GNE $67) expected to receive approval for Herceptin to treat metastatic breast cancer by year end (Sept. 2 FDA
Panel)
Immunex (IMNX $54-1/4) expected to receive approval for Enbrel to treat refractory rheumatoid arthritis by year end (Sept. 16 FDA
Panel)
Ligand (LGND $7-1/4) expected to receive approval of topical Panretin to treat Kaposi's sarcoma by year end

FDA Panel Meetings
Expected Timing Event
September 2, 1998 Genentech's Herceptin on FDA ODAC panel to treat metastatic breast cancer
September 16, 1998 Immunex's Enbrel on FDA panel to treat refractory rheumatoid arthritis

FDA Filings
Expected Timing Event
Q4:98/Q1:99
Alkermes (ALKS $12) & Genentech expected to file NDA for ProLease human growth hormone to treat hGH-deficient
children
Q4:98 Vertex (VRTX $16-1/8) & Glaxo (GLX $59-1/16) expected file NDA for Agenerase to treat HIV