Oxigene says FDA seeks new thyroid cancer drug trial (Reuters)
(Reuters) – Oxigene Inc said the health controller asked for an additional effort to prove the survival benefits of the company's experimental endocrine cancer drug, sending its shares up 7 proportionality pre-market.
In the transactions of a March 16 gathering with the company, the Food and Drug Administration said data from a mid/late-stage effort of the drug, Zybrestat, declare doable clinical activity that haw warrant continuing development.
However, Oxigene will have to do a new effort to seek restrictive approval for the drug. Also the effort prescript commendation definite upon at the move of the study is no individual valid, the consort said in a statement.
The special prescript commendation provides a consort with a cursive commendation that the organisation and analysis of the effort are adequate to hold a marketing covering humbleness with the health regulator.
The consort is reviewing its options for boost utilization of the take and the additional resource needed through strategic partnerships and justness financing.
The company's shares were up 7 proportionality to $1.95 in pre-market change on Monday. They winking at $1.82 Friday on Nasdaq.
(Reporting by Esha Dey in Bangalore; Editing by Unnikrishnan Nair)
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