No cross promotion but look at KZA announcement today on FDA fast track, OCC is in the process of doing this too and i'm pretty sure OCC will get it so onwards and updards, Greenleaf consultants engaged to get this done for OCC.
US FDA clinical development plan and regulatory pathwayDuring the quarter, the Company engaged Greenleaf Health (“Greenleaf”), a US based specialist regulatory consulting firm with particular expertise in cell and gene therapy product development and US FDA regulatory submissions and interactions. Greenleaf were engaged to review the Company’s clinical development plan and the draft US study protocol required to progress commercialisation in the US and assess the applicability of Ortho-ATI® for FDA expedited programs and priority review designations. Whilst the engagement of Greenleaf has delayed submission of the2 US, Japanese, European and Australian marketsTendon &Ligaments________________________2 Data presented at the American Academy of Orthopaedic Surgeons Annual Meeting in 2015Ph: +61 8 9360 2888 Fax: +61 8 9360 2899 www.orthocell.com.auInvestigation New Drug (“IND”) and Regenerative Medicine Advanced Therapy (“RMAT”) application, it will ensure the IND submission is tailored to the current regulatory guidelines and positions the Company to leverage the strategic benefits provided by applicable expedited programs and priority review designations.RMAT designation provides increased meeting opportunities with the FDA and ongoing guidance and support with regards to market entry applications and approvals. The Company remains focused on submitting the RMAT applications and is finalising submission documents.
KZA announcement points below FYI OCC will follow suit
US FDA AWARDS FAST TRACK DESIGNATION (FTD) TO PAXALISIB FOR GLIOBLASTOMA
Key Points• Fast Track Designation (FTD) is designed to expedite development of pharmaceutical products which demonstrate the potential to address unmet medical needs in serious or life-threatening conditions• FTD provides Kazia with substantially enhanced access to FDA, including opportunities for face-to-face meetings and written consultation throughout the remaining development of paxalisib• Drugs with FTD are eligible to apply for Accelerated Approval and Priority Review at the time of a New Drug Application (NDA) submission, which may result in faster product approval• FTD also allows for ‘rolling review’, whereby Kazia may submit completed sections of the paxalisib NDA as they become available, rather than at the end of development• Kazia consequently plans to begin initial preparatory activities for NDA filing for paxalisib in CY2021
OCC Price at posting:
42.0¢ Sentiment: Buy Disclosure: Held
and i'm pretty sure OCC will get it so onwards and updards, Greenleaf consultants engaged to get this done for OCC.
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