I am not sure if we can extrapolate his answer to
Post# of 153779
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Posted On: 09/21/2020 1:43:41 PM
Re: ClosetInvestor #57174
I am not sure if we can extrapolate his answer to mTNBC. Though the question was phrased with mTNBC in mind, as the questioner asked about the 12 patients from the spring, NPs answer seems to refer to the basket trial and upping the dosage from 525mg to 700mg.
Here's the transcript of his answer:
I would love to understand what happened to the first 12 patients. They had 0 CTCs but then COVID hit. Did COVID cause enough of a delay that we had to restart the trial due to missed dosing/visits? Are they still at 0 CTCs? Perhaps they found that CTCs alone won't sell the story to the FDA and they are looking for additional data to make that "powerful statement"?
I think we need to get a more thorough update before drawing any conclusions. Hopefully this Tuesday when he updates us on the cancer trials he can clarify where we are and where we are going.
Also weren't they supposed to have a BTD meeting with the FDA this month? I thought the goal was to clarify what we need to show to get BTD in cancer? Maybe they got some info back which factors into that "powerful statement"?
Here's the transcript of his answer:
Quote:
cancer trial we don't have clear signal that we want to see yet...we need more data...and the patient that has done wonders in our opinion is my own family member...I am the CEO of this company and so whatever I say people are going to have skepticism, and they should...so she is on 700mg and Dr. Jay L. has requested that we need to have 700mg...we have asked FDA last week and as soon as we get that we will see how the basket trial patients react with that but there is a lot of information that has to be gathered before we can come up with a powerful statement and we are not there yet
I would love to understand what happened to the first 12 patients. They had 0 CTCs but then COVID hit. Did COVID cause enough of a delay that we had to restart the trial due to missed dosing/visits? Are they still at 0 CTCs? Perhaps they found that CTCs alone won't sell the story to the FDA and they are looking for additional data to make that "powerful statement"?
I think we need to get a more thorough update before drawing any conclusions. Hopefully this Tuesday when he updates us on the cancer trials he can clarify where we are and where we are going.
Also weren't they supposed to have a BTD meeting with the FDA this month? I thought the goal was to clarify what we need to show to get BTD in cancer? Maybe they got some info back which factors into that "powerful statement"?
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