I'm in the same position on a pharma company, new cancer treatment. Science works but they can't seem to get approval for human clinical trials.
The FDA is, in my opinion, an inept agency full of corruption, so their CEO may just not have the weight of a Pfizer for approval. Could also be that it is our CEO who just can't get the job done. Either way, I could be holding a big bag here soon if I don't monitor constantly.
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