LONDON - The FDA has thrown Scotia Pharmaceuticals plc a lifeline, agreeing to a resubmission of the application for Foscan, a photodynamic therapy for the treatment of head and neck cancer.

The amended new drug application (NDA) will include data from 83 additional patients studied since the submission of the original NDA, based on a cohort of 64 patients. Scotia still has to agree with the FDA on what the criteria will be used to identify those patients who responded to treatment. The company aims to do that before Christmas, and resubmit the file by March 2001. It then would be on a 180-day approval track.

CEO Rob Dow told BioWorld International, "The important thing is that there is no need for new studies. The time and resource to get to a resolution is short and definable.

"This is the best outcome we could have gotten, given that you never resolve nonapprovable issues in one step."

Scotia, based in Stirling, Scotland, has enough money to last only until March. Dow said he now will seek more funds to see the company through to the FDA's verdict.

"I couldn't do that until I could tell investors with some confidence exactly what the position was," he said. "If it was going to be three years and another #25 million, very few people would want to put their hands in their pockets for that."

Scotia's share rose by 4.75 pence to 20.5 pence on the news. The company's shares fell by 63 percent to close at 45.5 pence on Sept. 26 when it announced that the FDA had ruled Foscan was not approvable.

The FDA helped Scotia to design the pivotal trial, originally involving 50 people and then expanded to 64. Although the trial was positive, the FDA decided the number of patients was too low. Dow said he believed the re-analysis would be positive. "We think there is sustained benefit, and 147 [patients] in cancer is a substantial database."

Dow said he also will reactivate negotiations with potential marketing partners for Foscan, and is also pursuing other ways of raising funds, including strategic alliances.

Hanging over all these efforts is the need to renegotiate a #50 million convertible bond that expires in March 2002. With Scotia's market capitalization standing at under #20 million, this will put off anyone buying the company. But unless investors put up more money the company will not survive until the FDA reaches its verdict on Foscan.