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Post by nylefty on Oct 18, 2021 22:30:18 GMT -5
Two months ago tomorrow (August 19th) MNKD closed at $3.97. Today it closed at $4.16.
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FDA delay
Oct 18, 2021 22:38:16 GMT -5
via mobile
Post by awesomo on Oct 18, 2021 22:38:16 GMT -5
Clan is an abrasive pumper, take with a heavy grain of salt. I don’t see anything alluding to this. Review his post on ST and then come back here and comment. I read his post and he posted a screenshot from a presentation in August. |
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FDA delay
Oct 19, 2021 0:54:11 GMT -5
via mobile
Post by parrerob on Oct 19, 2021 0:54:11 GMT -5
Question? Do we have now to ask for a type A meeting then resubmit the NDA?
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Post by akemp3000 on Oct 19, 2021 4:41:56 GMT -5
While the delay is disappointing, I like knowing the forthcoming approval, provided it happens, will not likely have an announcement date. While some of us repeatedly insisted the FDA decision would come on the PDUFA calendar date of October 15 as it did, we can now only look to "six months or sooner" for a decision. Hopefully there will be other good news in the meantime but this means a "surprise" announcement could come at any time a few months from now. When it does, it should light up this stock and this message board. This also puts significantly more uncertainty and pressure on shorting. Just enjoying a simple thought  |
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Post by hellodolly on Oct 19, 2021 5:24:06 GMT -5
Not sure where to put this and didn’t want to start a new thread, but obviously many of us are thinking about the potential now for dilution. When the leaseback deal got done, did certain folks have an inkling this CRL was coming? Also, we remember the MNKD executives’ bonus “formula” from past years. In order to make that formula spit out a favorable number, one of the metrics was (still is presumably?) getting the balance sheet looking better. What are the odds of another Xmas massacre or something of that nature? Quote, but obviously many of us are thinking about the potential now for dilution. Reply, This is the first time I have heard that many of us are thinking about potential dilution. Please name 5 people thinking about potential dilution. ("People are saying," "I'm hearing" sounds like a familiar catch phrase... used frequently... by a dementia patient I know of...) Hint, hint...my earlier post: "Have I added correct, we have about $352M after the sale-leaseback and a burn rate averaging the three last quarters of $30M (or avg of $10M a month) giving MNKD about 30 months?" I thought this kiboshes the notion for those who are "hard of hearing" or have dementia. |
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Post by prcgorman2 on Oct 19, 2021 6:58:36 GMT -5
Cretin is probably cleverer than I give them credit for, but I do agree in hindsight it appears that perhaps the sale/lease-back of most of the Connecticut facility in advance of the CRL was based on wanting to ensure extra cash was in the coffers because of a delay in revenue from manufacture and sale of Tyvaso DPI. I say perhaps because Mannkind announced the intention to sell and leaseback well in advance of the CRL and presumably before information was available from the FDA to use as input to a decision. In the end I do think the signs were there to the insiders that the extended cash runway was going to be advisable.
Now, it seems like 30 months of runway is more than sufficient so it makes me wonder if there is a ramp in there that’s not been talked about and I suppose it could be for Afrezza but not sure what the expectations are there. Yes, there are two trials in the works, but are anticipated positive results of those sufficient to ramp up salesforce? Would a label change be enough? Is there an insurance coverage improvement in the works from major providers? Don’t know, but things to ponder.
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Post by liane on Oct 19, 2021 7:13:15 GMT -5
You can never have too much cash. In the past, MNKD has been criticized for not raising cash at opportune times. They may not have had specific purposes for all the sale / leaseback cash. But for once, they played a card right.
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Post by prcgorman2 on Oct 19, 2021 7:16:58 GMT -5
100% agree. I remember watching an interview of the MNKD CEO (for a day) who had just retired as CEO from another small pharma he’d led to success and one of his comments that resonated with me was that things take twice as long and twice as much cash as you expect so make your estimates and then double them. (He may have only said twice as much cash, but it stuck with me as sage advice.)
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Post by sportsrancho on Oct 19, 2021 7:20:38 GMT -5
Seems to me they’re just ramping up the salesforce to ramp up the salesforce, you can go on LinkedIn and see how many positions are posted in other states.
Also their cars are wrapped in inhaleyourinsulin.com
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Post by peppy on Oct 19, 2021 7:34:57 GMT -5
Seems to me they’re just ramping up the salesforce to ramp up the salesforce, you can go on LinkedIn and see how many positions are posted in other states. Also their cars are wrapped in inhaleyourinsulin.com Perhaps some in roads have been laid with insurers? Perhaps MNKD is paying a rebate? |
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Post by Clement on Oct 19, 2021 7:46:18 GMT -5
Two months ago tomorrow (August 19th) MNKD closed at $3.97. Today it closed at $4.16. Six months ago MNKD closed at 4.16. Yesterday 4.16. During that six months the price ranged from 3.61 to 5.40. |
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Post by hellodolly on Oct 19, 2021 7:53:06 GMT -5
Cretin is probably cleverer than I give them credit for, but I do agree in hindsight it appears that perhaps the sale/lease-back of most of the Connecticut facility in advance of the CRL was based on wanting to ensure extra cash was in the coffers because of a delay in revenue from manufacture and sale of Tyvaso DPI. I say perhaps because Mannkind announced the intention to sell and leaseback well in advance of the CRL and presumably before information was available from the FDA to use as input to a decision. In the end I do think the signs were there to the insiders that the extended cash runway was going to be advisable. Now, it seems like 30 months of runway is more than sufficient so it makes me wonder if there is a ramp in there that’s not been talked about and I suppose it could be for Afrezza but not sure what the expectations are there. Yes, there are two trials in the works, but are anticipated positive results of those sufficient to ramp up salesforce? Would a label change be enough? Is there an insurance coverage improvement in the works from major providers? Don’t know, but things to ponder. Real estate, being real estate right now it doesn't take a mad scientist to figure out how to capitalize on your assets and turn them into extra cash, without subjecting your shareholders to dilution. IMHO, Mike C just gave us an early gift to allay the fears of another Christmas massacre because the timing in the real estate market made that an attractive alternative, as well as how MNKD is currently positioned with the emerging growth of their technology platform. The talk of dilution is always in the back of our minds...it should be as we've been invested in a non-revenue generating company that is slowly morphing into to a small revenue generating company, that is morphing into a mid-size generating revenue company and so forth. In summary, I don't believe for one second that a CRL (given the partner, the product and the people) was a consideration by Mike C., rather the timing of the benefits in the real estate market and financing options available were the impetus. Did he ever think of a CRL, they do everyday...it's part of their job. I'[m just not sold on the idea that a CRL was the motivation. Just my .02 cents. |
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Post by peppy on Oct 19, 2021 7:55:28 GMT -5
Cretin is probably cleverer than I give them credit for, but I do agree in hindsight it appears that perhaps the sale/lease-back of most of the Connecticut facility in advance of the CRL was based on wanting to ensure extra cash was in the coffers because of a delay in revenue from manufacture and sale of Tyvaso DPI. I say perhaps because Mannkind announced the intention to sell and leaseback well in advance of the CRL and presumably before information was available from the FDA to use as input to a decision. In the end I do think the signs were there to the insiders that the extended cash runway was going to be advisable. Now, it seems like 30 months of runway is more than sufficient so it makes me wonder if there is a ramp in there that’s not been talked about and I suppose it could be for Afrezza but not sure what the expectations are there. Yes, there are two trials in the works, but are anticipated positive results of those sufficient to ramp up salesforce? Would a label change be enough? Is there an insurance coverage improvement in the works from major providers? Don’t know, but things to ponder. Real estate, being real estate right now it doesn't take a mad scientist to figure out how to capitalize on your assets and turn them into extra cash, without subjecting your shareholders to dilution. IMHO, Mike C just gave us an early gift to allay the fears of another Christmas massacre because the timing in the real estate market made that an attractive alternative, as well as how MNKD is currently positioned with the emerging growth of their technology platform. The talk of dilution is always in the back of our minds...it should be as we've been invested in a non-revenue generating company that is slowly morphing into to a small revenue generating company, that is morphing into a mid-size generating revenue company and so forth. In summary, I don't believe for one second that a CRL (given the partner, the product and the people) was a consideration by Mike C., rather the timing of the benefits in the real estate market and financing options available. Just my .02 cents. 2% interest rates, I think all business has refinanced its debt. |
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Post by cretin11 on Oct 19, 2021 11:09:53 GMT -5
I appreciate the well reasoned responses to my question, with snarky comments kept mostly in check. We all seem to agree that dilution should not be needed this time (or ever again?), though it is a topic which many of us indeed have considered and are wise to consider until we become profitable.
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Post by peppy on Oct 19, 2021 11:16:48 GMT -5
I appreciate the well reasoned responses to my question, with snarky comments kept mostly in check. We all seem to agree that dilution should not be needed this time (or ever again?), though it is a topic which many of us indeed have considered and are wise to consider until we become profitable. Keep dancing with dilution Cretin. Spread your dilution dust..... make sure we have to pick it out of our noses every day, so we do not forget to pick our noses. |
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