I hope like hell that a BTD is possible for Nash. That would mean to me that the FDA believes that we are indeed the first drug to have results worthy of a BLA for Nash and will assign a team of FDA employees to help us achieve a well written BLA for Nash. This is what a BTD means to me. Help to achieve the BLA in a timely less than 6 months on average. This would be the ultimate reward for our long wait for an approval to happen.
History of failed Nash drugs with great phase 2 results are a long list. Probably slows the FDA response I believe. Will they put their neck out or will they say congratulations on your results and we will approve you to the next step for a phase 3 trial? I am trying to be realistic and would like to believe we more than have the opportunity for a BTD in mTNBC. It’s more likely to me and to be honest… we don’t have top line results on either one yet and that’s concerning.
We are all being optimistic in reality just believing we have something great happening. I want optimism as much or more than just about everyone but at times you just have to put your expectations in check for what we know and not for what we hope. HIV results are a known BLA possibility… just need a well written BLA and hopefully all the corrections have been dealt with. Then we have a real BLA. Until we see top line reports on Nash and mTNBC… we are just hoping and I am right there with you hoping… man… I want that more than anything… I am hoping but I am not putting the cart before the horse and expecting it. If I am a true optimist of Leronlimab and not locked in on perfect results coming… then would a big Pharma partner be more optimistic than I am? Maybe… I just don’t see it until the top line reports are PR’ed and we have that information in the bag as they say. Without knowing the information about possible BTD’s that are very possible and unproven but expecting offers and partners just seems to me a little premature. That’s my biggest fear now. That results are being held back because they can be. Not that they are in a NDA. That makes no sense to me. I am a… show me the money guy with results to prove it right now this is my current position.
Please don’t think I am being pessimistic. Because if you know me… you know I have been overly optimistic all along. This is a realistic view I have been trying to share. I am not trying to tear anything down or limit what I believe is a miracle molecule. We just need to get over the hump and get that dreaded first approval. However it comes… EUA, BTD to BLA or just a BLA process. BO or partnership is just way to optimistic even for me.
History of failed Nash drugs with great phase 2 results are a long list. Probably slows the FDA response I believe. Will they put their neck out or will they say congratulations on your results and we will approve you to the next step for a phase 3 trial? I am trying to be realistic and would like to believe we more than have the opportunity for a BTD in mTNBC. It’s more likely to me and to be honest… we don’t have top line results on either one yet and that’s concerning.
We are all being optimistic in reality just believing we have something great happening. I want optimism as much or more than just about everyone but at times you just have to put your expectations in check for what we know and not for what we hope. HIV results are a known BLA possibility… just need a well written BLA and hopefully all the corrections have been dealt with. Then we have a real BLA. Until we see top line reports on Nash and mTNBC… we are just hoping and I am right there with you hoping… man… I want that more than anything… I am hoping but I am not putting the cart before the horse and expecting it. If I am a true optimist of Leronlimab and not locked in on perfect results coming… then would a big Pharma partner be more optimistic than I am? Maybe… I just don’t see it until the top line reports are PR’ed and we have that information in the bag as they say. Without knowing the information about possible BTD’s that are very possible and unproven but expecting offers and partners just seems to me a little premature. That’s my biggest fear now. That results are being held back because they can be. Not that they are in a NDA. That makes no sense to me. I am a… show me the money guy with results to prove it right now this is my current position.
Please don’t think I am being pessimistic. Because if you know me… you know I have been overly optimistic all along. This is a realistic view I have been trying to share. I am not trying to tear anything down or limit what I believe is a miracle molecule. We just need to get over the hump and get that dreaded first approval. However it comes… EUA, BTD to BLA or just a BLA process. BO or partnership is just way to optimistic even for me.
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