Oct 6 (Reuters) – Polarean Imaging (POLX.L) acknowledged on Wednesday the U.S. Food and Drug Administration did not approve its utility for a fresh drug-instrument combination product, sending its shares tumbling 60%.
The scientific-stage company, which is making a product that uses MRI know-how to relieve diagnose lung illness, title and observe the medication, acknowledged the U.S. drug regulator had disorders that had been “technical or manufacturing-linked in nature”.
The corporate acknowledged it could maybe work on the disorders identified by the FDA and that it plans to resubmit a fresh drug utility for the product as soon as seemingly.
Polarean’s shares had been down 57% at 44.25 pence at 1341 GMT, hitting a one-twelve months low.
Reporting by Yadarisa Shabong in Bengaluru; Editing by Maju Samuel
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