Not to pick, I get that you were correcting the other guy. She did not say when they have not responded “after 3 months.” That’s not actually how it works. That implies that they actually respond at all when you are “approved” or that they were waiting 3 months and then when they did not respond they just kind of said, “I guess it’s OK”. If you are good to go, they do not respond ever at that point, and their silence is clear approval after 30’days. You don’t need to wait 3 months to see if they might yet respond, and just guess. They only have a set time period and the FDA has set that time period. That’s it. They give no one a latter of approval under the standard initial process and never after that, during a trial. It’s a well articulated process. They will tell you if you are not good to proceed they don’t want to create rights that can be litigated to suggest they awarded something without the full information. So they are very careful not to do that any time, to create any false expectations.
She simply explained you apply, they don’t respond after a period and you’re free to proceed. But I do not think she implied anything unusual or ambiguous. That is just the standard process always.
The actual approval process for IND’s, meaning every new clinical trial that is approved, is a “non-response” response, after 30 days. That is an actual and firm approval. The same goes for changes to the IND. Why would it be different for any approval of a change to the same trial if the first approval is always a firm non-response after a set period of time? If they do not want you to proceed, they tell you.
I own NWBO. My posts on iHub are always posted expressly as just my humble opinion (IMHO) and none are advice, just my opinion. I am NOT a financial advisor, and it is assumed that everyone is responsible for their own due diligence.
AI
