That’s right, he kinda giggled that rarely does the FDA simultaneously lift one hold and initiate another. So our partial hold (22 months) is lifted and a new (full hold) is in place while we respond to the FDA’s comments concerning the new HIV trial protocol. We should submit responses in January after working through the holidays, and 30 days later the FDA will respond, and theoretically we will start a 24 week trial with a very specific group by summer.
When you mention, “ I must of missed where he said that it has never happened before,” I think this is the cool part.
Let’s say it never happened that a hold was lifted while simultaneously initiating a new temporary one. This gave us the ability to PR last Thursday after the bounce to .40, that we would have a CC this Thursday to discuss the FDA’s comments on “The Hold” and the “Timeline” to resolve the concerns.
All the while, we knew the (22 week) hold was lifted. I mean, I didn’t, but…
Nothing about last Thursdays PR can be called into question. Because we were talking about the new hold.
In Bob Newhart voice…
Yes, ma’am the hold. No, no, no. Not that hold, The Hold. Yes, ma’am, I will enjoy my weekend. You too. Merry Christmas.
When you mention, “ I must of missed where he said that it has never happened before,” I think this is the cool part.
Let’s say it never happened that a hold was lifted while simultaneously initiating a new temporary one. This gave us the ability to PR last Thursday after the bounce to .40, that we would have a CC this Thursday to discuss the FDA’s comments on “The Hold” and the “Timeline” to resolve the concerns.
All the while, we knew the (22 week) hold was lifted. I mean, I didn’t, but…
Nothing about last Thursdays PR can be called into question. Because we were talking about the new hold.
In Bob Newhart voice…
Yes, ma’am the hold. No, no, no. Not that hold, The Hold. Yes, ma’am, I will enjoy my weekend. You too. Merry Christmas.
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