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Post by epc1355 on Sept 29, 2017 8:21:17 GMT -5
Does anyone know when or how we are supposed to hear about the label change decisions??
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Post by peppy on Sept 29, 2017 8:23:05 GMT -5
Does anyone know when or how we are supposed to hear about the label change decisions?? I believe it will be a public relations PR announcement. My bet is sla or liane will post as soon as the announcement is released.
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Post by myocat on Sept 29, 2017 8:24:27 GMT -5
It will be on Monday.
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Post by kbrion77 on Sept 29, 2017 8:26:24 GMT -5
I would agree, Monday is a safe bet. |
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Post by mnholdem on Sept 29, 2017 9:15:10 GMT -5
CEO Mike Castagna stated at Monday's investor conference that MannKind expects to receive the PDUFA decision "this Friday or over the weekend".
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Post by kball on Sept 29, 2017 9:23:35 GMT -5
Does anyone know when or how we are supposed to hear about the label change decisions?? I believe it will be a public relations PR announcement. My bet is sla or liane will post as soon as the announcement is released.
Put me down for 50 on SLA |
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Post by straightly on Sept 29, 2017 9:28:02 GMT -5
CEO Mike Castagna stated at Monday's investor conference that MannKind expects to receive the PDUFA decision "this Friday or over the weekend". I am disappointed that so many are speculating on this toss ups, and so few write home of our HUGE sales number of 417 Trx on the heel of 428 last week when we first broke 400 on our own! Frinds and family: just think that our sales is accelerating and our stock price is at a level and position of strength! In fact, if I were Mike, I would lock down my re-cap terms now. The label etc. can come sooner or later but we will be here to see it. |
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Post by orlon on Sept 29, 2017 9:40:26 GMT -5
No announcement about the PDUFA by the close of business today, based on previous PDUFA's, will mean back to below $2.00, maybe even $1.50 at the open on Monday.
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Post by madog365 on Sept 29, 2017 9:55:06 GMT -5
No announcement about the PDUFA by the close of business today, based on previous PDUFA's, will mean back to below $2.00, maybe even $1.50 at the open on Monday. Nah, the decision is expected by Monday per the CEO - Why would you assume anything will be announced today? |
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Post by peppy on Sept 29, 2017 10:04:05 GMT -5
Does anyone know when or how we are supposed to hear about the label change decisions?? I believe it will be a public relations PR announcement. My bet is sla or liane will post as soon as the announcement is released.
The real story will be MNKD volume and price movement, and we will all be looking for the PR.
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Post by mnholdem on Sept 29, 2017 10:25:30 GMT -5
I think a scarcity of available stock will also share the headlines.
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Post by hammer on Sept 29, 2017 10:33:40 GMT -5
Novo heard. Fiasp approved.
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Post by cretin11 on Sept 29, 2017 10:42:15 GMT -5
CEO Mike Castagna stated at Monday's investor conference that MannKind expects to receive the PDUFA decision "this Friday or over the weekend". I am disappointed that so many are speculating on this toss ups, and so few write home of our HUGE sales number of 417 Trx on the heel of 428 last week when we first broke 400 on our own! Frinds and family: just think that our sales is accelerating and our stock price is at a level and position of strength! In fact, if I were Mike, I would lock down my re-cap terms now. The label etc. can come sooner or later but we will be here to see it. I can't tell if this post is sarcastic? I hope nobody really considers the 417 Trx to be huge. Or our stock price at a level of "strength" (what does that even mean). I suppose if you started your position at under a dollar, you could say that. Definitely not my situation! |
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Post by brotherm1 on Sept 29, 2017 10:43:30 GMT -5
NVO is down slightly with the news
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Post by peppy on Sept 29, 2017 10:44:38 GMT -5
Novo heard. Fiasp approved. www.reuters.com/article/us-novo-nordisk-insulin-fda/u-s-fda-approves-novo-nordisk-fast-acting-insulin-fiasp-idUSKCN1C4296
(Reuters) - The U.S. Food and Drug Administration on Friday approved Novo Nordisk’s fast-acting insulin to treat diabetes.
The product, known as Fiasp, is designed to help diabetics control post-meal spikes in blood sugar. It is already approved in Canada and Europe.
Fiasp, or faster acting insulin asparte, is designed to work faster than existing fast-acting insulin such as Eli Lilly and Co’s Humalog and Novo Nordisk’s own NovoLog, known as NovoRapid outside the United States.
Last year the FDA declined to approve the product and requested additional information.
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