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Post by rockstarrick on Sept 25, 2014 11:07:40 GMT -5
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Post by gamblerjag on Sept 25, 2014 11:22:49 GMT -5
Question.. We all know that most stocks follow the market (even if they shouldn't).... However, with MNKD in early 2015 reporting their earnings from sale of Afrezza.. do you think that MNKD will follow the market if the DOW/SP retraces 20-30%.. I know it shouldn't but just a little concerned if there is a market downturn. MNKD may not follow the same % but will it go down with so much good stuff going on? I'm wondering if the only way we see MNKD at it's truly accurate price is at a buyout, and the pps jumps to buyout price? Thought? Thanks,
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Post by rockstarrick on Sept 25, 2014 15:46:23 GMT -5
Hey Gambler, I don't expect to see much action with the S/P just because the waiting period is over unless Sanofi starts a pre launch marketing plan. I think they are required to wait 6 months from the date of approval before they can advertise on television.
I don't expect the S/P to drop much though, we are just too close to pre launch, European approval filing, and any studies or announcements with the Technosphere pipeline. I guess what I'm saying is, for the most part, we are finished with the hard times, no we wait for sales, then buyout of Afrezza, still holding a position in Mannkind Technologies for more future gains. The most significant accomplishment is we are going to market, there are a few chances for good news between now and then that could give us a boost, but the real boost will be when sales are known we can put a real value on Afrezza and move forward with a buyout. I'm thinking the buyout process will start after 6 months of sales, but then there is the possibility that Sanofi will want to buy it before if Al let's them.
As far as I'm concerned, if you want free money, load the boat. Afrezza will be the new mealtime insulin standard of care for most diabetics. Good luck Gambler, and remember, it's no longer a question of if, it's now a question of when, we have won this battle. See you at the party. RSR
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Post by dreamboatcruise on Sept 25, 2014 15:59:57 GMT -5
I doubt a buy out as long as Al is alive, which hopefully will be a good long time to come.
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Post by mnholdem on Sept 25, 2014 16:01:01 GMT -5
Question.. We all know that most stocks follow the market (even if they shouldn't).... However, with MNKD in early 2015 reporting their earnings from sale of Afrezza.. do you think that MNKD will follow the market if the DOW/SP retraces 20-30%.. I know it shouldn't but just a little concerned if there is a market downturn. MNKD may not follow the same % but will it go down with so much good stuff going on? I'm wondering if the only way we see MNKD at it's truly accurate price is at a buyout, and the pps jumps to buyout price? Thought? Thanks, Absolutely...NOT! The reasons I believe this are as many as there are upcoming events for this company. EU and Japan, FDA label improvements, continued development and testing, not to mention Technosphere partnerships. I've also learned, at least from the manufacturing side, that medicine is affected less by economic trends than are other industries. Folks don't need less drugs when there are market corrections. We are a long way from the point in the product life cycle where share price will move based on whether the company misses eps estimates by a few cents, and investors turn to other stocks will provide a better ROI. |
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Post by mannmade on Sept 25, 2014 16:34:38 GMT -5
Question.. We all know that most stocks follow the market (even if they shouldn't).... However, with MNKD in early 2015 reporting their earnings from sale of Afrezza.. do you think that MNKD will follow the market if the DOW/SP retraces 20-30%.. I know it shouldn't but just a little concerned if there is a market downturn. MNKD may not follow the same % but will it go down with so much good stuff going on? I'm wondering if the only way we see MNKD at it's truly accurate price is at a buyout, and the pps jumps to buyout price? Thought? Thanks, Absolutely...NOT! The reasons I believe this are as many as there are upcoming events for this company. EU and Japan, FDA label improvements, continued development and testing, not to mention Technosphere partnerships. I've also learned, at least from the manufacturing side, that medicine is affected less by economic trends than are other industries. Folks don't need less drugs when there are market corrections. We are a long way from the point in the product life cycle where share price will move based on whether the company misses eps estimates by a few cents, and investors turn to other stocks will provide a better ROI. Agree with above and believe there was some previous posts about upcoming binary events. However I think the one thing that could help a bit is to know more about the triggers for milestone payments. Eg: Does the beginning of production in November trigger a release of funds (I doubt it) but you get the idea... As any payments triggered by reaching an operational milestone that come before sales related triggers will help give a very positive momentum not to mention more cash/revenue to the corp bottom line which with the transfer of most R&D costs to Sanofi's books in 4th Q should begin to look much better to the big funds/investors. Also I think as have mentioned before that announcing Afrezza has been accepted on the insurance formularies will also help pps move up a bit I would think, (although as we all know good news in the inverse universe that is Mannkind may actually have the opposite effect of upward movement in pps) Just my 2 cents and mho... |
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Post by gamblerjag on Sept 25, 2014 17:00:03 GMT -5
thanks Mannmade and Mholdem. appreciate your thoughts
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Post by nuklerfizzacist on Sept 25, 2014 18:35:11 GMT -5
Hi to everyone here...I'm new to this board but I'm not so new to MNKD (but wish I were..if you get my drift..lol) anyhow, saw this post and since I play in regulations of the gov't sort I noted it was a "draft document for public comment" and not a finalized accepted rule delineating document intended for implementation, so I went to the FDA site (where this does in fact come from kudos to the discoverer of this document). At the FDA site I was unable to locate a finalized version of this so I went to our govt's Code of Federal Regulations where I found this..I'll post a link to spare the eyes www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=202.1&SearchTerm=advertisementIn this CFR I was unable to locate any time frames associated with FDA review of planned advertisements. The wording of the CFR and the draft guideline are both written seemingly to not cause a delay in advertisement but does put the onus on the "applicant" to either give the FDA time to review or not..(weird but that's how both documents read). in other words lots of Mays and Ifs in both documents..not written in stone. CFR wording: (4) Any advertisement may be submitted to the Food and Drug Administration prior to publication for comment. If the advertiser is notified that the submitted advertisement is not in violation and, at some subsequent time, the Food and Drug Administration changes its opinion, the advertiser will be so notified and will be given a reasonable time for correction before any regulatory action is taken under this section. Notification to the advertiser that a proposed advertisement is or is not considered to be in violation shall be in written form. Guidance wording: Under section 503B, FDA may require that a TV ad be submitted to FDA for review not later than 45 days before the sponsor intends to disseminate the ad (21 U.S.C. 353b(a); see also 21 U.S.C. 333(g)(3)(C)). The 45-day review clock for proposed DTC TV ads subject to the pre- dissemination review provision begins when CDER or CBER has received a complete pre- dissemination review package from a sponsor. B. What happens if FDA is not able to complete its review within the 45-day time frame? FDA will notify the sponsor if the Agency is not able to provide comments within the 45 calendar day time frame. FDA’s notification will include an estimate of the date on which FDA expects to provide its comments. In such situations, the sponsor should determine whether it will wait for FDA’s comments before disseminating the TV ad or whether it will disseminate the TV ad without waiting for FDA’s comments. The sponsor should notify FDA of its decision. Once the 45-day review time has elapsed, there is no specific legal consequence resulting from disseminating the proposed TV ad without waiting for FDA’s comments see section VII.A). However, once an ad is disseminated, the sponsor is at risk of enforcement action if the ad violates the FD&C Act and implementing FDA regulations. I'd suspect MNKD will of course be submitting any planned advertisements for FDA review, but I suspect that unless MNKD puts something out that is patently false or off-label, the review time frame is pretty much a non-issue. just my opinion. fizzacist P.S. Thanks for all the great information from the lot of you! |
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Post by BlueCat on Sept 25, 2014 20:02:14 GMT -5
But it wouldn't be MNKD putting it out, but SNY. And now that we're through HSR, they can work on that submit, meet both the 6 month and 45 day requirement for ... January!
Happy New Years diabetics.
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Post by rockstarrick on Sept 25, 2014 20:18:28 GMT -5
BlueCat. That was the reason for the post, actually I was on my way out the door when I found this. With a 6 month timeframe for the first TV. ad, the ad should be at the FDA before November 1, and I would expect the first Television Ad around December 27th. I didn't get time to read the entire article, just thought it was exciting to see we will be submitting complete marketing Ads to the FDA in just over 4 weeks. RSR
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Post by nuklerfizzacist on Sept 25, 2014 21:21:35 GMT -5
BlueCat. That was the reason for the post, actually I was on my way out the door when I found this. With a 6 month timeframe for the first TV. ad, the ad should be at the FDA before November 1, and I would expect the first Television Ad around December 27th. I didn't get time to read the entire article, just thought it was exciting to see we will be submitting complete marketing Ads to the FDA in just over 4 weeks. RSR Can you point out where the 6 months timeframe that you reference is coming from? maybe I'm just missing it? thanks |
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Post by BlueCat on Sept 25, 2014 21:44:16 GMT -5
6 months from FDA Approval on June 27th brings us to December 27th. 45 days before that ... and voila! Beginning of November.
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Post by BlueCat on Sept 25, 2014 21:46:27 GMT -5
From a marketing perspective - depending on how much they want to open the French purse, a great strategy for TV ads would be to start airing them over New Year's weekend - when a lot of people are home, watching things on TV. Including the NYC ball drop, etc etc. Ad opportunities abound.
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Post by BlueCat on Sept 25, 2014 21:55:29 GMT -5
Here's something fun. Got a great idea for an Afrezza commercial?
===Ad spot 1:
Diabetes is a global epidemic, sometimes leading to fatal complications.
For many, the most basic experience of sharing a meal during the holidays equals stabbing themselves with needles.
Start the New Year right. Don't inject, inhale.
Afrezza.
===Ad spot 2:
Have you ever considered how many syringes get dumped into our oceans, waterways and landfills every year?
The diabetes epidemic alone contributes X number of these syringes per year.
But now diabetics have a better choice. They can save their skin, and our planet.
Afrezza.
Got one?
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Post by mnholdem on Sept 26, 2014 0:07:06 GMT -5
I'm not sure if label restrictions will prevent Sanofi from showing how Afrezza mimicks a healthy pancreas, but my catch phrase would be "Afrezza for mealtimes. As easy as taking a breath."
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