Yeah… I overstated that comment. What I really meant was good results will probably only get us a phase 3 opportunity. I wouldn’t count on a BTD for Nash. Nash is the unicorn of indications for all of big Pharma. Everyone gets to phase 3 but no Pharma actually gets the whole BLA approval. Making it one of the most sought after drug therapy for a disease that hasn’t happen yet. There are many diseases we don’t have cures or therapy for but this Nash/NAFLD Is a huge population world wide and would be one of… if not the biggest Block Buster drug in the history of pharmaceutical.
I have tempered my expectations on a lot of things lately. I hope like hell we get the phase 3 for Nash and we knock it out of the park on the trial. It would be huge. I am hopeful for huge like everyone else. I don’t expect a BTD because we have not done the biopsy trial which is what every other drug has flamed out and failed on. Until we achieve great results by the 2 different liver biopsy trial… we wait.
I don’t believe the FDA is going to throw out a BTD on results that are preliminary and will expect us like everyone before us to prove our completed use to verify actual liver improvement that is the standard set with the biopsy. It doesn’t mean to me that we can’t get there… it just means that we need to prove ourselves yet again.
You don’t get buy out or partnership offers last few years unless you have an actual BLA approval. Nash is a ways away. Great results may move the needle but how much? I don’t know… but nothing but a future approval may be the only thing moving our needle.
I compare Nader now to the little boy who cried wolf once to often and nobody believes him any more. He is gone but his legacy will drift until we get an approval. Don’t get me wrong… I loved Nader for the information he freely dealt us all. But he also allowed us to be shorted hard by giving all that information. Kind of a double edged sword.
My hope now is leaning to a BTD on mTNBC being our first possible approval and maybe a dark horse Covid EUA will surprise us instead. HIV Combo is 9 months at best away from an approval if we have Fast Track status and file and that’s a big if… if we get the BLA filed by end of this quarter. I hope nothing holds that up. So my speculation is we could still have a few approvals this year. Maybe as many as 3 but that’s being optimistic without knowing all the cards involved. But until we actually bag an approval we will not have a buy out or partnership because big Pharma stopped risking billions on buy out of unproven not approved drugs or biotechs. I won’t believe there is NDA happening right now. Only that we just have changed to only release “material events” PR’s now. It’s what makes sense to me and anything else like BO or Partner is just to optimistic for me without an approval of some kind.
I have tempered my expectations on a lot of things lately. I hope like hell we get the phase 3 for Nash and we knock it out of the park on the trial. It would be huge. I am hopeful for huge like everyone else. I don’t expect a BTD because we have not done the biopsy trial which is what every other drug has flamed out and failed on. Until we achieve great results by the 2 different liver biopsy trial… we wait.
I don’t believe the FDA is going to throw out a BTD on results that are preliminary and will expect us like everyone before us to prove our completed use to verify actual liver improvement that is the standard set with the biopsy. It doesn’t mean to me that we can’t get there… it just means that we need to prove ourselves yet again.
You don’t get buy out or partnership offers last few years unless you have an actual BLA approval. Nash is a ways away. Great results may move the needle but how much? I don’t know… but nothing but a future approval may be the only thing moving our needle.
I compare Nader now to the little boy who cried wolf once to often and nobody believes him any more. He is gone but his legacy will drift until we get an approval. Don’t get me wrong… I loved Nader for the information he freely dealt us all. But he also allowed us to be shorted hard by giving all that information. Kind of a double edged sword.
My hope now is leaning to a BTD on mTNBC being our first possible approval and maybe a dark horse Covid EUA will surprise us instead. HIV Combo is 9 months at best away from an approval if we have Fast Track status and file and that’s a big if… if we get the BLA filed by end of this quarter. I hope nothing holds that up. So my speculation is we could still have a few approvals this year. Maybe as many as 3 but that’s being optimistic without knowing all the cards involved. But until we actually bag an approval we will not have a buy out or partnership because big Pharma stopped risking billions on buy out of unproven not approved drugs or biotechs. I won’t believe there is NDA happening right now. Only that we just have changed to only release “material events” PR’s now. It’s what makes sense to me and anything else like BO or Partner is just to optimistic for me without an approval of some kind.
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