Speaker: What are we going to talk about?

Dr. Bercu:  Request for extension to respond to the IRB?  It has your name next to it.

Ms. Epley: It must be Dr. Kirkpatrick

Dr. Bercu:  Right there, Kirkpatrick

Ms. Epley:  Ooohh!  Do we have this thing?

Dr. Bercu: No.

Ms. Epley: Uh…we have been holding a protocol for Dr. Kirkpatrick, I don’t know if you all remember, this is the one where he wanted to induce coma for five days up, and we sent him 24 things that he needed to address. It has now been a year and four months, I believe.  But, he has been in negotiations, let’s say, with FDA, although I’m not sure how they explain that and don’t even think you need to know. It has… we gave him a deadline of March 26th to respond so that…I mean… of March 20th so that we could present his response to the board today, but he requested an extension. I would like to recommend that you all accept that request and send him a message that if all 24 items are not addressed by the time that the next agenda runs, the study will be closed and any consideration of that study will require a new submission.

Dr. Bercu:  OK. So we’re going to e-mail our position.

Speaker: I’m going to put it in a formal letter if that’s what the board agrees to.

Dr. Bercu:  Ok. In order for that to happen we need the board to make a…a member of the board make a motion. Is there anybody else…

Speaker:  May I make a motion and then a request? (Unintelligible)

Speaker:  Yes… (Unintelligible)

Speaker:  And my motion is that we tell him he’s gotto re-submit right now.

Speaker: Well that’s what if we would not  …. approve the extension ….  (Unintelligible)

Speaker:  Yes.

Speaker:  OK. It’s been a year and a half; I mean…generally it’s… isn’t it ninety days?

Speaker:   (Unintelligible)….    At the last…the last I had, it was reviewed was April of last year. And at that time they still needed to again, submit for IND and a host of other items which will be (Unintelligible), so…and then we haven’t gotten…

Dr. Bercu: Ok, so that’s the motion. Is there a second?

Dr. Bercu:  This vote’s for the recommendation. Is there a second to that?

Speaker:  To the motion?

Speaker: You asked to the motion if it were proposed?

Dr. Bercu:   The motion that he proposed.

Male Speaker:   OK

Ms. Epley: So that…I get prepared for this. What the IRB is requesting that at this point he re-submit a new application with all of the previously requested changes incorporated into that application. Because, there were 24 items covered.

Male Speaker:  I have a question then. What is the likelihood that if whatever he is working on is going to stop before starting in the next thirty days, and if not then I’m thinking we should go his way.

Dr. Bercu:  You can’t…the board can choose to go that route. I think that the path of least resistance here, although it may end up, ending up the same place, is to vote this one down and, and, and do Norma’s recommendation, because then it’ll show that he had no reason to ask us for anything else. He could tell anybody in the world that we were bad and we’re nasty…Uh…here he’s seemingly asking what seems reasonable, although the board may not view it as reasonable.

Speaker:  But he is responding, requesting an extension to a deadline that we already gave him. He was told that it had to be ready for this one. And he called back and said he needed another extension. It’s been almost a  (Unintelligible)

Ms. Epley:  Um, well he’s claimed, and I have no way, and this is my fault, I have no way of verifying or refuting when he actually received my correspondence. And his claim is that he didn’t receive it until one week before it was due then.

Dr. Bercu:  He needed more time. That’s his claim

Ms. Epley:  He is… I have to tell you, he has filed a formal complaint against, and it could be IRB, but intrinsic against Dr. Bercu and I if you want to know the truth about it. And we have spent hours with this man. So, I don’t want to tell you to tip-toe around this. I want you to do what you think is best. Clearly, a year out, we’re going to have to go back to TGH and see if they’re still agreeing to not charge over the $70,000 that they first agreed to. We’re going to have to make sure that there are the beds still available that he needed…I mean…

 Male Speaker:  Well, he’s going to have to do that.

Ms. Epley:  He’s going to, yeah, but we’re going to have to have some assurances. So, I’m not opposed to your motion, quite frankly. I know Doctor Bercu wants to…

Dr. Bercu:  I don’t want to give him another excuse.

Ms. Epley:  Well, quite frankly I don’t care to. Ha, Ha, Ha,

Dr. Bercu:  Alright …Doctor Kumar, you’re in charge.

Female Speaker:  Well, I concur with Doctor Lush and that there’s supposed to be proof and if he goes public (Unintelligible)…uh…uh…if it’s something…a new protocol, it should be new, especially with 28 or so amendments that he had to meet, that’s a new protocol altogether.

Speaker: Well, it depends.

Speaker:  And so to it should be equitable, I mean if I’m over by 90 days, I’m tardy.  But, you know, I’m…

Dr. Bercu:  But, we do make exceptions if…There’s a difference between 90 days and a year, but if you were to ask us for an extension beyond 90 days, we would grant you.

Speaker:  Yeah, and then justify …..  maybe my final report is not ready…

Dr. Bercu:  Right.

Speaker: … or it hasn’t been accepted or hasn’t been analyzed or something like that. But this is common (Unintelligible) or other consequences involved, and (Unintelligible)

Male Speaker:   Did he say why did it take so long to respond?

Ms. Epley:   His argue…his point has…now granted, he hasn’t addressed any of the others, issues, that his point is that the IRB doesn’t have the authority to make him go to FDA and obtain an IND. He has focused one year’s attention on that one issue.

Male Speaker:   OK.

Dr. Bercu:   He’s been in dialogue somewhere about that. And…um…he’s gotten other people involved, and… uh…we…It may end up being a complete confrontation anyway, but my bias would be to give him another month, as unfair as it may seem. The board will have to decide that.

Ms. Epley:   What about if we give him one month in which to submit a rebut…, because…you’re right, 24 items is a revised protocol?

Dr. Bercu:   But we do have other people have 24 that are not…

Female Speaker: Right, but they’ve come back with a great details of… (Unintelligible)

Speaker:   They respond…(Unintelligible)

Speaker:   Right.            

Speaker:  He’s been trying to get (Unintelligible) he’s been trying to get around (Unintelligible)

Dr. Bercu:   He thinks we’re abrogating our responsibility when we ask the FDA to have a…a…like we ask everybody else in this kind of situation where we say “just ask the FDA”.

Ms. Epley:   He disagrees that an IND is needed. And all you have to do is call FDA and make that determination.

Speaker:   Could we do this then? Could we give him that month and say this is final, I mean, this is how it has to be done?  I mean, if he’s given an argument with that and say, look if you don’t get it done buy then, it’s over?

Speaker:  And then there is 27 obvious things here (Unintelligible) to be responded to

Speaker:   The IND application set aside, he has not responded to all the other items…

Speaker:   Right

Speaker:   (Unintelligible)…he’s probably not going to do it anyway.

Dr. Bercu:   But suppose he does? Suppose he…if he doesn’t, it doesn’t even come to the board it’s just closed. I think that what Norma originally said, although it wasn’t…it’s not in front of the floor now…is she is recommending that if he doesn’t complete all 24, it’s not even going to come to the board, it’s closed.

Speaker:  (Unintelligible)

Dr. Bercu:   Well…I think that the members who are here for this discussion should vote this up or down (Unintelligible)…if it’s…Um...voted, that’s the way it goes if it’s voted a yes vote. If it’s not, then we’ll have another. OK, so…All in favor are

Speaker:  Just hear my last question. What exactly …did you hear him say he will do…you give him thirty days and he doesn’t follow through , are we going to be the same, I am assuming, that you and I are…he will issue the same complaint if we close the study(Unintelligible)

Dr. Bercu:   We don’t…He has no right to stand on.

Speaker:  (Unintelligible) complaint from the IRB point of view?

Speaker:   Yes. That’s… (Unintelligible)

Speaker:   What was that 30 days  (Unintelligible)

Speaker:   But, I feel that…that 30 days would give him more time to argue.

Dr. Bercu:   But there’s no argument. No argument.

Speaker:  Given the data.

Speaker:   Hum?

EVERYONE:    (Unintelligible)

Speaker:  (Unintelligible)…You are not hearing him out now.

Dr. Bercu:  It gives him a little more potency in his complaint against the IRB. And, Uh…by giving him this opportunity and he fails, how are they possibly…he could still say, “You didn’t give me a chance”, as idiotic as that may seem.

Speaker:  (Unintelligible)

Dr. Bercu:   So…uh, that Doctor Munster  wasn’t here, so I think we should move it up or down…Um… and then we’ll have another motion, so are all in favor? (Unintelligible)

Speaker:  Are we voting on Dr. Lush’s?

Speaker:    Yes, Dr. Lushes, we are voting on Dr. Lushes.

Everyone :   (Unintelligible)

Speaker:  All in favor of my motion in that…..

Speaker:   And it’s supposed to end this?

Speaker and Male speaker:  Yes, Yeah.

Dr. Bercu:   Two…OK. All opposed? OK. So, it goes down.  Today, I do appreciate (Unintelligible). OK…Um…For the second and third (Unintelligible) it’s a different position to get to the point. Now, with the motions we want…what was that?  Well yeah. OK. Somebody else want to make a motion?

Speaker:   Motion dropped with the extension as requested and as represented by Norma.

Dr. Bercu:   Do you want to add…uh…your suggestion that it would be, “ you must respond to all 24, or it’s not coming…

Speaker:  Right.

Dr. Bercu:  …either dead on arrival

Speaker:  Right.

Dr. Bercu:  ….or  dead prior to arrival.

Speaker:   The two motions (Unintelligible)

Speaker:   NO!

Speaker:  The first one has gone down.

Speaker:   OK. That’s what you’re doing.

Speaker:   Yeah.

Ms. Epley:  My recommendation for a new motion is that we extend him that courtesy with the understanding that we will receive a revised application or consent with all of the 24 items addressed. If they are not addressed it will not be forwarded to the IRB for review…

Dr. Bercu:   OK. Can I have a second?

Ms. Epley: …The study will be closed.

Dr. Bercu:   Can I have a second to that motion as a date? Yeah. That’s what I wanted to add to that is what is the date he has to get it back to the board; it’s not a month from today?

Speaker:   He says its 30 days and it doesn’t go…. (Unintelligible)

Speaker:  No. It has to be (Unintelligible)

Dr. Bercu:   Can you tell us what that date is and we’ll put it into the motion.

Speaker:   I said it will go out on April 30th.

Speaker:  Then that’s what it meant.

Speaker:   (Unintelligible)    to make sure he has everything there.

Speaker:  Well that won’t give him his 30 days from the 20th to respond.

Dr. Bercu:   Well shall now make it 30 days from the 20th.

Speaker:  OK.

Dr. Bercu:   That’s what he gets. How’s that sound?

Dr. Bercu:   What is that day, does somebody want to…because we’re going to give a specific date.

Speaker:   30 days from the 20th in my schedule?

Speaker:   Yes.

Speaker:  April 20th or April 19th, one of the two.

Dr. Bercu:   Um… Yeah because, February only has 28 days.

Speaker:   NO. March has 31 days.

Speaker :   We’re talking March now.

Speaker:  Right.

Dr. Bercu:   When is the date?  19th?

Female Speaker:  Alright. April the 19th.

Dr. Bercu:   April the 19th. It must be in your hands.  What day of the week is that?

Speaker:   It’s a Thursday, I think.

Speaker:   OK.

Ms. Epley:  And, should we get it we can then send it out to you electronically because the agenda will (Unintelligible)

Dr. Bercu:   Thursday the 19th.  But, do we want to make it clear that he’d been given that full amount there, which is the two days after the date we get fax everything…Um…? OK. We’ll leave it at that. The 19th to mark the end. Now, um, is it 5:00 P.M.?

Speaker:   Yep!

Dr. Bercu:   Or 11:00 P.M.?

Ms. Epley:  5:00 P.M.

Dr. Bercu:   You know what college Professor’s say, 5:00 P.M.

Speaker:   (Unintelligible) college Professors?

Speaker:   We only get there at 4:30 ha, ha, ha…

Speaker:  ‘til noon of that daythen we could at least look at it.

Dr. Bercu:   OK.  All in favor of that?  OK. Uh…no, I think we better stick to the original discussion. OK. Anybody opposed to that?  OK. It’s not unanimous, OK. Alright. Thank you. We’ll uh let you know. Next item is the continuing reviews…I got to get used to this. Doctor Dielman, you have this…Oh, Dr. Kumar, yes.

End of Discussion.