“Definetly not. The fda provided this guidance s
Post# of 153773
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Posted On: 12/26/2020 9:36:39 AM
“Definetly not. The fda provided this guidance so we could continue saving lives.”
The FDA provided the guidance because CYDY asked the FDA about EINDs and a label extension. I don’t believe for a minute that the FDA reached out to CYDY. Yes, we’re in a pandemic but the FDA is still taking 4 day weekends for holidays so they’re not thumbing through COVID trials, calling companies for updates. The onus is on a company to conduct the trial and submit the data, not the FDA.
“Despite any negative spin you want to put on this development.”
I didn’t put any negative spin on this development. I simply pointed out that I haven’t seen evidence that the FDA has seen efficacy data from the S/C trial and as a result, made the EIND and open label extension recommendations. Investors have been claiming since June that the FDA has been viewing the data but again, there’s no evidence of that. When the 50% interim release was pending and we got a PR about a CC 5 days later, investors were posting theories about the FDA meeting over the weekend to view the data for approval.
The EIND and potential label extension is great news for patients, but I don’t believe it’s indicative of imminent approval. If it were indicative of approval and the FDA has in fact seen the data, as may suggest, the FDA would just approve the drug and skip the EIND/label extension process. CYDY still has to receive the full 28 day data, analyze it, release the results and then make a decision to file for EUA in the US, UK, etc.
The FDA provided the guidance because CYDY asked the FDA about EINDs and a label extension. I don’t believe for a minute that the FDA reached out to CYDY. Yes, we’re in a pandemic but the FDA is still taking 4 day weekends for holidays so they’re not thumbing through COVID trials, calling companies for updates. The onus is on a company to conduct the trial and submit the data, not the FDA.
“Despite any negative spin you want to put on this development.”
I didn’t put any negative spin on this development. I simply pointed out that I haven’t seen evidence that the FDA has seen efficacy data from the S/C trial and as a result, made the EIND and open label extension recommendations. Investors have been claiming since June that the FDA has been viewing the data but again, there’s no evidence of that. When the 50% interim release was pending and we got a PR about a CC 5 days later, investors were posting theories about the FDA meeting over the weekend to view the data for approval.
The EIND and potential label extension is great news for patients, but I don’t believe it’s indicative of imminent approval. If it were indicative of approval and the FDA has in fact seen the data, as may suggest, the FDA would just approve the drug and skip the EIND/label extension process. CYDY still has to receive the full 28 day data, analyze it, release the results and then make a decision to file for EUA in the US, UK, etc.
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