EXCLUSIVE: Alzamend Neuro Tells Benzinga 'Safety aspects of AL001 development may qualify for a 505(b)(2) NDA pathway for FDA approval'
Portfolio Pulse from Benzinga Newsdesk
Alzamend Neuro has indicated to Benzinga that the safety aspects of its AL001 development could be eligible for a 505(b)(2) New Drug Application (NDA) pathway with the FDA, which could streamline the approval process.
November 20, 2023 | 12:30 pm
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Alzamend Neuro's potential eligibility for a 505(b)(2) NDA pathway for AL001 could lead to a streamlined FDA approval process, possibly accelerating the drug's development and market entry.
The 505(b)(2) NDA pathway can allow for a faster approval process by the FDA, which is generally viewed positively by investors as it can lead to earlier market entry and revenue generation. However, the actual impact will depend on further details and confirmation from the FDA.
CONFIDENCE 75
IMPORTANCE 80
RELEVANCE 100