Replies to post #686997 on NorthWest Biotherapeutics Inc (NWBO)
04/24/24 8:21 PM
04/24/24 8:26 PM
04/24/24 11:30 PM
04/25/24 4:04 AM
During the Medicines and Healthcare products Regulatory Agency (MHRA) Marketing Authorisation Application (MAA) approval period, pharmaceutical companies must adhere to strict regulations regarding what information they can share about the product pending approval. This includes communications with retailers or the general public.
Under these regulations, companies are restricted from promoting or making claims about the safety, efficacy, or marketing of the product until it has received official approval. The primary reason for this is to ensure that all public information about a drug is accurate and substantiated by the MHRA's assessment, preventing misinformation and protecting public health.
However, companies can share factual, non-promotional information about the product, such as its development status, the progress of the MAA, and general scientific findings that are not directly linked to the promotional claims about the product's benefits or risks. For example, they might inform retailers about the submission of the MAA or general updates on the approval process timeline without making specific claims about the product's potential success or market availability.
Such communications must be carefully managed to avoid crossing into promotional territory, which could be viewed as a breach of regulatory guidelines. Therefore, while not completely restricted from discussing the product, companies must navigate these rules carefully to remain compliant with MHRA regulations.
04/25/24 4:23 AM
04/25/24 5:58 AM
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