The wait goes on for Avacta following MHRA submission error

No news is good news? Unfortunately this wasn’t the case for Avacta and its shareholders regrading submissions to the MHRA.

Earlier in May, the diagnostics and cancer therapies specialist revealed that it had submitted the declaration of conformity to the MHRA on 10 May.

However, it seems that the submission did not actually find its way to the MHRA until the end of May, 28 May to be precise.

The error was reportedly due to Mologic sub-contracting the duty of submissions to a regulatory consultancy to both the MHRA and a competent authority in the European Union.

While disappointing, the company was eager to point out that the error will not hold up commercial movement:

In the meantime, the Company has continued its discussions with distributors and customers for the AffiDX antigen test and does not anticipate that the error will cause a delay to first commercial sales of the product.

Update on SARS-CoV-2 Antigen Lateral Flow Test Regulatory Submissions

The company also sought to further clarify a previous response to speculation post about what was believed to have been a ‘fake’ email posted on social media regarding an MHRA filing.

It turns out the email was not ‘fake’ but rather to be for a different Mologic test:

Avacta can also confirm that the SARS-CoV-2 test referenced in a social media post on 27 May, highlighting an email that had been obtained from the MHRA reporting rejection of a filing of a Declaration of Conformity of a SARS-CoV-2 antigen test from Mologic, was an unrelated Mologic antigen test. It was not the Avacta AffiDX SARS-CoV-2 antigen lateral flow test as purported in the social media post.

The Avacta share price is currently trading at 236p, climbing down from an intra-month high of around 275p.

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