Tuesday, March 29, 2022 12:26:43 PM
Suppose I entertain this off the wall argument.
Yes, I give you that IF they get to the point where they are truly ready to file an IND application there is a strong chance they will get fast track approval. So it is fair for them to say that fast track is anticipated after filing the IND application. Also, the 'anticipated' language is likely alluding to them anticipating they will apply for fast track designation. But I won't even get into that argument with you all as it is definitely opinionated and I know I'm not changing anyone's mind on that.
However, you have to get to the point of filing first. For ADVA, they have to complete the IND enabling studies, which is no small task. It isn't just the toxicity studies in mice, although it is a big leg up that they already have that completed. They also have to secure a GMP certed manufacturer, also no small task. Both of these need to be done before they apply, which means they haven't applied yet. They are still working on collecting everything needed for the application.
SBFM-PL4 (antiviral now, because PL4 has likely failed) is even further behind, having not yet completed mice studies. They still have to identify a lead candidate for this, so there is absolutely positively no way they have even started the IND application for Covid.
You can anticipate that once all your ducks are in a row, you will receive fast track approval. That doesn't mean you'll get to that point. I anticipate that if I play in rush hour traffic every day, I'll get hit by a car. But I'm not going to be playing in rush hour traffic, so that outcome likely won't come to fruition.
Yes, I give you that IF they get to the point where they are truly ready to file an IND application there is a strong chance they will get fast track approval. So it is fair for them to say that fast track is anticipated after filing the IND application. Also, the 'anticipated' language is likely alluding to them anticipating they will apply for fast track designation. But I won't even get into that argument with you all as it is definitely opinionated and I know I'm not changing anyone's mind on that.
However, you have to get to the point of filing first. For ADVA, they have to complete the IND enabling studies, which is no small task. It isn't just the toxicity studies in mice, although it is a big leg up that they already have that completed. They also have to secure a GMP certed manufacturer, also no small task. Both of these need to be done before they apply, which means they haven't applied yet. They are still working on collecting everything needed for the application.
SBFM-PL4 (antiviral now, because PL4 has likely failed) is even further behind, having not yet completed mice studies. They still have to identify a lead candidate for this, so there is absolutely positively no way they have even started the IND application for Covid.
You can anticipate that once all your ducks are in a row, you will receive fast track approval. That doesn't mean you'll get to that point. I anticipate that if I play in rush hour traffic every day, I'll get hit by a car. But I'm not going to be playing in rush hour traffic, so that outcome likely won't come to fruition.
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