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Post by akemp3000 on Dec 17, 2022 7:42:31 GMT -5
Thanks Peppy and everyone for the shared optimism. If this ride up comes to pass as many are now anticipating, at what point does BP step in and say it's time to take this little biotech out? And by take out, I mean take over. There's no real answer, just pointing out IMO this will happen sooner or later. My wild guess would be soon after pediatric approval as one or more will see how the future is evolving.
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Post by Clement on Dec 17, 2022 9:55:55 GMT -5
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Post by akemp3000 on Dec 17, 2022 10:17:41 GMT -5
The FDA allots "up to" 10 months as a standard time frame for approval. If given "Priority Review", this is shortened to six months. Pediatric approval could come in 2024.
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Post by Clement on Dec 17, 2022 11:24:16 GMT -5
The FDA allots "up to" 10 months as a standard time frame for approval. If given "Priority Review", this is shortened to six months. Pediatric approval could come in 2024. You left out submission after completion of the study and acceptance of the submission by FDA. Why do you think MNKD would get Priority Review for Afrezza Peds? |
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Post by boca1girl on Dec 17, 2022 11:29:54 GMT -5
I think the priority review would be used for a PEDS approval for Tyvaso-DPI
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Post by Thundersnow on Dec 17, 2022 12:10:40 GMT -5
I think the priority review would be used for a PEDS approval for Tyvaso-DPI Looks like people are getting confused. The "new" Priority Review Voucher will be used for the Tyvaso DPI For Kids. We do not know id MNKD has a voucher for the Afrezza PEDS Approval. I doubt they would pay to shorten he timing by 4 months. I believe the FDA can decide it they will give Priority Review or the Normal Review. |
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Post by prcgorman2 on Dec 17, 2022 13:38:49 GMT -5
The FDA allots "up to" 10 months as a standard time frame for approval. If given "Priority Review", this is shortened to six months. Pediatric approval could come in 2024. You left out submission after completion of the study and acceptance of the submission by FDA. Why do you think MNKD would get Priority Review for Afrezza Peds? 2024 or 2025 is the timeframe. Late 2025 possible but is there a reason to believe likely? I don’t know how long submission and acceptance typically takes, but I would hope those are ordinarily maybe 90 days to complete the both of them after trial completion. i.e., submitted and approved 90 days after April. So maybe mid-2025? I am still curious how much a successful trial and approval will mean to weekly TRx. Will this trial be what is needed to convince subscribers that Afrezza is good to prescribe (10 years after initial commercialization???)? I am honestly not very hopeful. I think a head-to-head trial against competitive products to prove superiority and SAFETY is needed and has been all along. I didn’t used to think that, but now I’m convinced. |
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Post by mymann on Dec 18, 2022 14:37:04 GMT -5
I am sorry. It looks like I am irritable. Sorry. mymann . Direct hit on my nervous system, however point taken. I am sorry for the harsh words. added, MNKD price is back into the $4 dollar limbo. Here is the thing with this charting pattern, it is the rule, the golden rule. The point of break out was $4.40. The pattern is good on the break and hold. This is a weekly pattern. The pattern should have some push. so far price has done the slow weekly push, and was picking up. The overall markets are going down large percentages now. We have to see what shakes out. OVERall, MNKD revenues are going up. It's future secure for now. It's bills can be met. 1.25 billion dollar market cap. My apologies, too much beer and frustration. I really don't know what I'm talking about. Please egnore my stupidity. Just glad to read about very informative data about mnkd. Keep up the good work. Thank you everyone on this board. |
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Post by mytakeonit on Dec 18, 2022 14:46:11 GMT -5
Volume X. Tell me when. (Perfect place to post this)
A former neighbor of mine that moved to Florida several years back ... returned to Hawaii for a visit and came by to visit his old neighborhood. He saw my house and decided to ring my doorbell.
We talked and his excitement grew when he asked about my stock trading that I emailed him about. I reminded him that I had advised him previously to buy MNKD when it was at $2.80 ... he laughed and said "How's that doing?"
I told him that it is at $5.11 and headed for $10. BOOM !!! He whipped out his phone and was trying to call his broker. I had to tell him that the stock market is closed. Ha!
But, that's mytakeonit
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Post by peppy on Dec 19, 2022 12:45:45 GMT -5
MNKD volume at the half day of trade,
real time, 2,818,951
summary, 2,822,830
Avg. Volume 4,500,793
$4.875. -0.235. (-4.5988%)
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Post by peppy on Dec 19, 2022 16:22:13 GMT -5
MNKD volume at the half day of trade, real time, 2,818,951 summary, 2,822,830 Avg. Volume 4,500,793 $4.875. -0.235. (-4.5988%) MNKD Nasdaq real time volume, 6,653,470 shares. MNKD Nasdaq summary volume, 6,617,982 Avg. Volume 4,500,793 $4.90. -0.21 (-4.11%)   IBB     |
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Post by peppy on Dec 20, 2022 10:02:27 GMT -5
MNKD volume at 30 mins of trade,
real time, 273,225 shares.
summary, 295,170
Avg. Volume 4,545,625
$4.98. +0.089. (+1.8163%)
As of 10:00AM EST. Market open.
Recall the resistance at $4.97/$4.98 old swing highs
next resistances, $5.05, $5.24. $5.31 hit Friday.
At 1 hour of trade,
real time, 729,987 shares
summary, 745,301
Avg. Volume 4,545,625
5.10+0.20 (+3.98%)
As of 10:30AM EST. Market open.
More volume is coming in the higher MNKD moves, what we want to see.
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Post by peppy on Dec 20, 2022 12:01:01 GMT -5
MNKD volume at 90 mins of trade, real time, 1,491,493 shares. summary, 1,498,916 Avg. Volume 4,545,625 $5.15. +0.25 (+5.10%) As of 12:00PM EST. Market open. The pattern seems to be working,  |
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Post by hellodolly on Dec 20, 2022 12:19:51 GMT -5
MNKD volume at 90 mins of trade, real time, 1,491,493 shares. summary, 1,498,916 Avg. Volume 4,545,625 $5.15. +0.25 (+5.10%) As of 12:00PM EST. Market open. The pattern seems to be working, Keeping on eye on $5.30 area, also Fib ext (.786) area. Fib ext (1) at $5.65 area, next S/R Fib at (1.618) $6.63, next S/R I love these natural numbers found in nature, LOL. |
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Post by novafett on Dec 20, 2022 12:37:43 GMT -5
Pulls out pom-pons and cheers.. "Let's crack that $5.31!!" |
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