The Neuren Chairman’s said in his address at last year’s AGM
…we are working closely with a number of parties to refine the physical and technical attributes of NNZ-2566, as well as optimise the manufacturing process and projected unit costs for commercial supply of drug product. I am pleased to report that we have already identified significant opportunity in this area.
The way I see it, prudence by management would necessitate that Neuren’s manufacturing arrangements be well advanced prior to applying for breakthrough therapy designation.
If BTD were to be granted, it’s possible that the FDA might invite early submission of an NDA. However, the FDA says that it may only approve a New Drug Application (NDA)
...if, among other requirements, the methods used in, and the facilities and controls used for, the manufacture, processing, packing, and testing of the drug are found adequate, and ensure and preserve its identity, strength, quality, and purity.
Each NDA has a Chemistry, Manufacturing, and Controls (CMC) section to be completed which includes analytical test methods for the drug product, specifications of the drug product and drug components, and a general description of the product’s manufacturing and control procedures.
The FDA’s assessment of the CMC section (as part of its NDA review) always includes a review of submitted information and frequently includes an on-site inspection of manufacturing operations.
According to one FDA reviewer, it’s lack of readiness for such manufacturing inspections that is one of the reasons for delays in drug approval. This is particularly pertinent for a drug granted breakthrough therapy designation and accelerated approval, as these approvals can dramatically compress the drug development timeline. Consequently, management has to get both their manufacturing and marketing strategies sorted out in a much shorter time frame.
The FDA has said that there have been cases where their ability to review and approve a drug has outpaced the sponsor’s ability to scale the manufacturing process appropriately to support the marketing and distribution of its new drug.
In summary, the company’s statement about manufacturing is likely neither BS nor a reflection of some grand vision for the future, but rather an indicator of good management of the drug development and approval process.
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(20min delay)