Absolutely no drug application takes this long (3 plus years from data lock 39 months and counting) to submit. Anyone who has held biotechs knows that applications get submitted usually within 6 months to a year. The range is 6 months to 15 months (if they are slow). But on this fantasy land board, "Haste Makes Waste", "This is small biotech", "This is the first autologous product", "This is perfectly normal", "Automation, Automation, Automation". Sorry DNDN was the first and they submitted in a timely fashion regardless of what Hoff and his aliases say even when provided with timelines. DNDN submitted and recevied a CRL, had to run a new trial and re-submit (which they did within 6 months of data and 6 months later subsequently got approved). And the NWBO has provided vague updates on automation, so i'm not sure why anyone would think this Application has automation included when the manual process was used in the trials. Too many dreamers and pumpers on this board. Few provide useful factual information. I see the All solid tumors, RWE, Automation, Project Orbis BS Pumping has died down now that it is proven they struggle submit a single RA application. "it's out of our hands"? Really, you hire contractors to do your job and it is out of your hands.....More BS coming out of their mouths.
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