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news.The Paul Ehrlich Institute (PEI) has raised questions on Allergy Therapeutics' marketing authorization application of Grass MATA MPL (marketed as Pollinex Quattro/ Complete).
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Pollinex Quattro is a four injection therapeutic vaccine which is being developed for the treatment of allergic conditions which offers same season relief in as little as three weeks after treatment.
Allergy Therapeutics said it will adress all the issues and work in co-operation with PEI to provide a complete response later this year.
Pollinex Quattro will continue to be sold as a named patient product in Germany until the MAA is approved.
On the other hand, the US Food and Drug Administration (FDA) has confirmed that the clinical hold on the investigational new drug applications (INDs) for the three MATA-MPL products will be lifted once the protocols have been agreed.
The company is now in the process of submitting protocols to the FDA.