ENDORSEMENT FROM THE UK REGULATORY BODY
(MEDICINES & HEALTHCARE PRODUCTS REGULATORY AGENCY, MHRA)
Neuro-Bio has just been awarded a ‘Passport of Innovation’ from the MHRA. The company is very much at the forefront of this new concept of ‘Innovation Licensing and Access Pathway’(ILAP), and hence there is no track record to refer to: however the stated goal of this new program is to support and encourage innovation in the post Brexit world. This program is clearly differentiated by the collaborative nature of the stakeholders MHRA/MHSE/NICE /SMC/HRA/NIHR . By including all of these stakeholders at the start of the process there is an enhanced opportunity to accelerate access to the market, and getting the product to patients as soon as possible. Benefits and key points for investors:
1 ILAP will potentially expedite access to both DAD and AD market (key stakeholder involvement and engagement/buy in)
2 ILAP may reduce cost of developing product development through extensive stakeholder advice, and efficiencies.
3 ILAP approval will be recognised by other global stakeholders as ‘significant” (namely EMA and FDA and may help with the ODD designations)
4 Collaborative approach by all stakeholders for the ongoing development of TDP in both indications.
This certification shows that our national regulatory body, akin to the FDA and EMA where applications are also pending, is supporting our prototype drug NBP14 as a novel and innovative product. In this process the MHRA and key stakeholders recognise that the drug is a product worthy of support and guidance to accelerate the development of the product to meet an unmet medical need for patients.