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Post by Deleted on Oct 3, 2016 20:28:11 GMT -5
1. Mnkd gonna conduct EpiHale clinical trial for the next 3-4 mos. After that, Mnkd will review the result w/ FDA early 1Q17. The whole process to FDA approval is ~ 10 mos. Gonna conduct? Arent they already in progress and should have been started middle of the year as i recall from the presentations and hence the other two pipeline drugs were on hold?
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Post by mnholdem on Oct 3, 2016 20:49:55 GMT -5
There is pre-clinical, then whatever clinical trial(s) that are needed to gather IND data. It seems that they are adhering to the timeline published earlier.
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Post by gamblerjag on Oct 3, 2016 20:53:42 GMT -5
ok.. That's good that ATL fans are diehards.. Charger fans not so much. Too much bitterness over the last 8 years. Understandably so IMO. If other teams fans didn't come to our stadium to fill up the seats Chargers fans would fill up about 1/2 to 2/3 of the seats..
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Post by lakers on Oct 3, 2016 21:46:02 GMT -5
There is pre-clinical, then whatever clinical trial(s) that are needed to gather IND data. It seems that they are adhering to the timeline published earlier. Most likely Mnkd will partner up for EpiHale as the FDA approval process is expensive. It can't go alone. Mnkd needs to look for a partner now as it takes time. It will have more leverage w/ an IND in hand and ample cash. This is where Sny settlement could help. I think PAHale holds good potential. The mkt is dominated by UT whose inhaling device is a huge bong while PAHale's PD/PK profile is better. Matt has been traveling in the last 2 weeks, perhaps busy negotiating something?
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Post by papanigon on Oct 3, 2016 21:52:03 GMT -5
Even with all this aside, I don't see a help for our pps.
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Post by bradleysbest on Oct 3, 2016 22:08:21 GMT -5
With the MLB playoffs starting if you or someone you know goes to a game look through a game program for an Afrezza advertisement. Keep us in the loop on this. Thx
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Post by gonetotown on Oct 3, 2016 22:15:32 GMT -5
With the MLB playoffs starting if you or someone you know goes to a game look through a game program for an Afrezza advertisement. Keep us in the loop on this. Thx So the "pamphlets" are the game day programs?
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Post by bradleysbest on Oct 3, 2016 22:17:59 GMT -5
My understanding is there will be Afrezza ads/info in the MLB playoff programs.
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Post by mnkdfann on Oct 3, 2016 22:19:50 GMT -5
My understanding is there will be Afrezza ads/info in the MLB playoff programs. Do people buy MLB playoff programs for the ads, like people used to buy Playboy for the articles?
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Post by agedhippie on Oct 4, 2016 7:42:04 GMT -5
There is pre-clinical, then whatever clinical trial(s) that are needed to gather IND data. It seems that they are adhering to the timeline published earlier. Most likely Mnkd will partner up for EpiHale as the FDA approval process is expensive. It can't go alone. Mnkd needs to look for a partner now as it takes time. It will have more leverage w/ an IND in hand and ample cash. This is where Sny settlement could help. I think PAHale holds good potential. The mkt is dominated by UT whose inhaling device is a huge bong while PAHale's PD/PK profile is better. Matt has been traveling in the last 2 weeks, perhaps busy negotiating something? I agree with mnholden. I see no indication that Mannkind has strayed from the plan Matt announced to conduct trials next year. If trials were being conducted this year you would see the filings in Clinical Trials and there aren't any so I think the idea of trials this year is fiction. The other advantage of having the trials next year is that it doesn't impact the cash burn at a particularly critical moment. EpiHale served a purpose which was to raise awareness of Mannkind as with the LA Times article. Matt's traveling probably has more to do with raising money than finding a partner for EpiHale - well I certainly hope it does because that's a lot more critical.
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Post by mnholdem on Oct 4, 2016 9:01:43 GMT -5
I suspect that Pfeffer and Thompson (maybe even Kresa?) were in a conference Room at 55 Corporate Dr, Bridgewater, NJ 08807 and that "raising money" would be one way to describe the meetings.
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Post by therealisaching on Oct 4, 2016 9:07:15 GMT -5
I suspect that Pfeffer and Thompson (maybe even Kresa?) were in a conference Room at 55 Corporate Dr, Bridgewater, NJ 08807 and that "raising money" would be one way to describe the meetings. Don't tease
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Post by nylefty on Oct 4, 2016 9:22:09 GMT -5
I suspect that Pfeffer and Thompson (maybe even Kresa?) were in a conference Room at 55 Corporate Dr, Bridgewater, NJ 08807 and that "raising money" would be one way to describe the meetings. Don't tease Sanofi's North American headquarters.
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Post by kbrion77 on Oct 4, 2016 9:24:51 GMT -5
Most likely Mnkd will partner up for EpiHale as the FDA approval process is expensive. It can't go alone. Mnkd needs to look for a partner now as it takes time. It will have more leverage w/ an IND in hand and ample cash. This is where Sny settlement could help. I think PAHale holds good potential. The mkt is dominated by UT whose inhaling device is a huge bong while PAHale's PD/PK profile is better. Matt has been traveling in the last 2 weeks, perhaps busy negotiating something? I agree with mnholden. I see no indication that Mannkind has strayed from the plan Matt announced to conduct trials next year. If trials were being conducted this year you would see the filings in Clinical Trials and there aren't any so I think the idea of trials this year is fiction. The other advantage of having the trials next year is that it doesn't impact the cash burn at a particularly critical moment. EpiHale served a purpose which was to raise awareness of Mannkind as with the LA Times article. Matt's traveling probably has more to do with raising money than finding a partner for EpiHale - well I certainly hope it does because that's a lot more critical. They would probably have to give away the license (that's if anyone is even interested in it) right now. Unless there are other sources of cash that are nothing short of a miracle they have no leverage sitting at a table with another pharma. Just imagine if you were the other pharma and MNKD came to you asking for what we all hope the economics of a deal would be, you would say don't let the door hit you on the way out.
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Post by Deleted on Oct 4, 2016 10:07:38 GMT -5
Given all the money out there, are there not PE firms who look for healthcare deals who also have a stable of operating execs who would cut off body parts in return for a comp package that included equity to make them wealthy assuming success? Given how hot the epi space is now, seems possible but PE firms probably don't want to put up a lot of $$ so how about some risk mitigation by getting a hedge fund or two to share the risk.
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