ARS pharma

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anonymous said:
CRL means Complete Response Letter. Sometime it is a delay to provide more data and sometimes the FDA questions are so many that it effectively means the product never gets approved. Either way it’s not good news.
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it looks like the question was, What will this mean? Not what does CRL mean, I’m guessing e wet one knows that. What will this mean to all those getting ready to start? I’ve seen this before and the company moved forward.
 




anonymous said:
CRL means Complete Response Letter. Sometime it is a delay to provide more data and sometimes the FDA questions are so many that it effectively means the product never gets approved. Either way it’s not good news.
Click to expand...


Dead on this is not something that is usually corrected quickly . CRL indicates that the FDA has conducted a complete review of the data in an NDA, ANDA, or BLA submission and subsequently found that it cannot approve the application in its present form. Each CRL details the reasons that the submission was found to be inadequate and often includes recommendations from the FDA on how the sponsor can address the deficiencies.
 








anonymous said:
Dead on this is not something that is usually corrected quickly . CRL indicates that the FDA has conducted a complete review of the data in an NDA, ANDA, or BLA submission and subsequently found that it cannot approve the application in its present form. Each CRL details the reasons that the submission was found to be inadequate and often includes recommendations from the FDA on how the sponsor can address the deficiencies.
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OMG I’m numb, devastated this is going to be catastrophic to many individuals if they are not able to onboard as planned.
 
















Regardless of FDA CRL, carefully consider if you really want to be part of this risky venture. If the conditions of the CRL are ever met, and that’s a big if, there will be intense pressure from shareholders on down to the lowest level salespeople.
 




anonymous said:
Regardless of FDA CRL, carefully consider if you really want to be part of this risky venture. If the conditions of the CRL are ever met, and that’s a big if, there will be intense pressure from shareholders on down to the lowest level salespeople.
Click to expand...

Very true. This market and opportunity is easy to overestimate. The reason ARS is doing it themselves is because they couldn’t get anyone to pay the value THEY put on it earlier. This means pressure is going to be intense.

the CCO is a shady climber who is only looking to get paid. The field is as disposable as TP.
 




























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