Imugene has received multiple FDA IND's from the FDA. To date all clinical trials Imugene have sought approval for from the FDA have been granted as such. The ongoing exemplary safety profile of Imugene's immunotherapy products has enabled Imugene to obtain approvals for trials ahead of time, as noted with the company's recent approval to conduct a clinical trial for their Oncarlytics treatment arm in conjunction with Blincyto. I should perhaps reiterate that MD and CEO Leslie Chong and Dr Jakob Dupont of Team Imugene have multiple FDA Product approvals between them. I am confident given their track record, the recent history of trial approvals for Imugene's products, and Professor Fong's collaborations with the FDA (in combination with the City of Hope), that contrary to some posters opinions, the FDA is comfortable in working with Imugene to develop much needed products to meet the huge unmet need facing hospital wards with solid tumour patients throughout the US.
In short comparing Imugene to other biotech stocks who may or may not been approved by the FDA is pointless. Imugene already have the staff with the FDA runs on the board, and a track record of success with the regulatory body. Investors may choose to question many decisions and outcomes pertaining to company performance, but Imugene's relationship with the FDA should not be one of them. The company's ability to design clinical trials that are acceptable to the FDA in spite of their complexity, is their strength. Look no further than the current Vaxinia MAST Trial as a prime example, where close to 100 patients are able to be enrolled with multiple cancer indications across multiple administration arms, in IT, IV and in combination (i.e., with Keytruda). As product inventor Professor Fong noted in his recent address to shareholders, this is a remarkable achievement in and of itself.
Todays correspondence is advantageous in that it moves Imugene one step closer to being in a position where they can manufacture their own drugs for sale in the US, should that need arise. It's ostensibly another string to their commercial bow to be applauded by a market streaming out for revenue from the group. There are undoubtedly many steps further in the company's eventual commercial destination, but from where I sit this is a constructive, practical and worthwhile one, adding significant value to Imugene's value proposition.
DYOR - Seek investment advice as and when required - Opinions only
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