Hard no here as well. The final straw for me was
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Posted On: 09/15/2020 4:30:20 PM
Hard no here as well. The final straw for me was the RTF letter on the BLA, which had been discussed/promised for at least a year. It's time to finish something before asking for more compensation.
Edit: Yes, I know Amarex handled the BLA. Who hired Amarex? Yes, I know the FDA may have been difficult in going from 350 mg to 700 mg. Who designed the protocols - or hired those who did? Ultimately, management takes responsibility for the BLA issues. This would be a different company right now if the BLA was in and a PDUFA date issued. I believe it would be a different conversation for COVID too ... if this drug was approaching - or HAD - its first approval already.
Edit: Yes, I know Amarex handled the BLA. Who hired Amarex? Yes, I know the FDA may have been difficult in going from 350 mg to 700 mg. Who designed the protocols - or hired those who did? Ultimately, management takes responsibility for the BLA issues. This would be a different company right now if the BLA was in and a PDUFA date issued. I believe it would be a different conversation for COVID too ... if this drug was approaching - or HAD - its first approval already.
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