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Biotech / Medical : Texas Biotech (TXB) -- Ignore unavailable to you. Want to Upgrade?


To: Bill Tomko who wrote (668)5/11/1998 1:45:00 PM
From: E. Graphs  Respond to of 834
 
Bill,

The TXB site shows the release....and some other items that may be of interest to the thread.

>>Texas Biotechnology will request a meeting with the FDA to confirm the exact requirements for further consideration of the drug by the FDA.<<

I will assume that there are requirements for further consideration then.

tbc.com

E



To: Bill Tomko who wrote (668)5/11/1998 2:39:00 PM
From: E. Graphs  Respond to of 834
 
>>INTERVIEW-Texas Bio says hopeful on Novastan

biz.yahoo.com

By Jeff Mamera

NEW YORK, May 11 (Reuters) - Texas Biotechnology Corp. (TXB - news) said Monday it continues to be hopeful for U.S. Food and Drug Administration approval of its anti-coagulant, Novastan, despite a non-approval letter from the agency.

''We're certainly not giving up on this,'' said David McWilliams, the company's president and chief executive said in an interview.

Houston-based Texas Biotechnology, earlier on Monday, said the FDA did not approve Novastan for marketing. The news sparked a selloff of the company's shares, whose market value was halved.

At midday, the shares were off 4-3/16 at 4-13/16 on the American Stock Exchange on volume of more than 1.2 million shares.

Earlier, the shares touched 4-1/8.

''We believe we can turn this situation with the FDA around and bring our follow-up to the level that would be approvable,'' McWilliams said.

McWilliams said that within the next 30 days, the company will meet with the FDA to confirm the exact requirements for further consideration of the drug.

Texas Biotechnology in August 1997 submitted Novastan as a treatment for patients with conditions caused by an immune reaction to heparin, the most widely used anti-blood clotting therapy.

McWilliams did not say how much money Texas Biotechnology has spent so far in developing Novastan.

''I don't have that number right at the top of my head -- many millions,'' he said.''

Novastan was further along in the pipeline than any other of the company's drugs, McWilliams added. As a result, the company has invested more money on it than on any of its other drugs to date, he said.

However, other drugs currently in Phase II development by the company have more market potential than Novastan, including a new drug for heart-failure and an asthma drug, McWilliams added.

Williams said that despite the setback on Novastan, the company has on hand about $44 million cash -- enough for two years of business.

(--Wall Street desk, 212-859-1730))