(Total Views: 401)
Posted On: 04/14/2020 11:19:48 AM
Post# of 154115
Re: SouthernGold #27455
I think this is a healthy debate. 
I think we as a group have gravitated toward an opinion that the FDA is trying to prevent us from gaining approval. I just dont think that is true. They are putting us through the same protocols as everyone else. If it works, they want to approve it. But they will not accept andectodal evidence. They require an approval. I dont think they should, given the circumstances, but it is what it is.
If we provide marginal data on 50 patients we wont get an approval. But if the evidence is irrefutable, we will IMO.
I agree 100% that we need to dedicate resources to completing this. However, I do not think that submission of the BLA is going to send our share price noticably higher. I know that this has been the subject of much debate already, but my opinion is that the only catalysts that will have a significant impact on share price are the ones that involve revenue (approval, licensing deals) and the catalysts that provide credibility (BTD, licensing deals, completed trials, peer reviewed studies)
I dont think submitting a BLA fits either of these boxes.
Quote:
Your faith in FDA giving us approval for CV is much stronger than mine
Read More: https://investorshangout.com/post/newpost/605...z6JbHanD5x
I think we as a group have gravitated toward an opinion that the FDA is trying to prevent us from gaining approval. I just dont think that is true. They are putting us through the same protocols as everyone else. If it works, they want to approve it. But they will not accept andectodal evidence. They require an approval. I dont think they should, given the circumstances, but it is what it is.
If we provide marginal data on 50 patients we wont get an approval. But if the evidence is irrefutable, we will IMO.
Quote:
Why not have a resource like Kelly sole task to be BLA submission
Read More: https://investorshangout.com/post/newpost/605...z6JbIB4cl5
I agree 100% that we need to dedicate resources to completing this. However, I do not think that submission of the BLA is going to send our share price noticably higher. I know that this has been the subject of much debate already, but my opinion is that the only catalysts that will have a significant impact on share price are the ones that involve revenue (approval, licensing deals) and the catalysts that provide credibility (BTD, licensing deals, completed trials, peer reviewed studies)
I dont think submitting a BLA fits either of these boxes.
(5)
(0)
