Hopefully, we will soon see some revenue coming in from the Early Access Program below.
The US Food and Drug Administration (FDA) and European Commission have granted Orphan Drug designation to ATL1103 for treatment of Acromegaly.The Company executed a global agreement with innovative early access provider myTomorrows (Amsterdam, The Netherlands) to implement an Early Access Program (EAP) for ATL1103, for the treatment of acromegaly to be established in select countries within the European Union (EU).
Labelled and packaged in the UK, the ATL1103 drug product is available to be shipped to myTomorrows in the Netherlands for EAP distribution subject to myTomorrows clearance for importation.
Additional (to what has been required to support clinical trial usage) product data and documentation has had to be, and is being generated in order for the ATL1103 drug product to be supplied in accordance with the required regulatory and quality standards for use in the EAP. Antisense Therapeutics is working closely with myTomorrows in order that this process may be finalised and product imported and released by myTomorrows for use in the EAP.
Great to see more facts and less 'hype statements' in the report.
Unlike some other biotech companies . . . . . .
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