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Post by stockwhisperer on Sept 21, 2021 10:15:49 GMT -5
No idea. Just seems that the time & cost for the facility inspection makes no sense if there were drug issues that would result in delays or no approval. Kinda seems like putting the cart before the horse. Can not find anything about the order in which the FDA does these things - maybe simultaneously. It’s all a secret until the great reveal. In any case - all opinions & speculations. Charts will react to sentiment. Would guess, like most anticipated FDA decisions - the sp will start moving up some, soon. You must have missed it when listening to the webcasts. The inspection was not only for Tyvaso dpi but a periodic inspection of the plant(ie for Afrezza as well) and is why it took so long. Last inspection was when Afrezza was getting approval so they were overdue. No, I heard that on the call. Thanks |
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Post by stockwhisperer on Sept 21, 2021 10:50:02 GMT -5
Stock price is definitely in wait and see what the FDA does mode. Flag comes to a point around Thanksgiving. Sometime soon it will break north or south. That it will. Seem to be differing opinions on when the FDA will give their response ranging from, anytime between now & Oct 15th to anytime between now & Oct 31st to Oct 15th exactly. Would think volume & volatility will kick in once the crowd believes it is getting close. I appreciate the chart folks - can not image how challenging that must be but they too must know the rumors & news will ultimately, drive those charts - which way this time… we should know soon. |
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Post by akemp3000 on Sept 21, 2021 11:05:24 GMT -5
I've tracked many biotech stocks prior to a PDUFA date. I can't recall ever seeing one where all bets were placed several weeks in advance and the price remained stable until the announcement. IMO, we should see significant movement prior to the announcement. As always, nothing's ever normal about MNKD plus the FDA ruling is more about UTHR than MNKD to many biotech investors. Not so much on a MNKD message board. GLTA
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Post by peppy on Sept 21, 2021 11:46:42 GMT -5
MNKD Nasdaq volume at the half day of trade,
real time, 363,095
summary, 579,264
4.5360. +0.0560 (+1.25%)
As of 12:46PM EDT. Market open.
minutes between trades.
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Post by peppy on Sept 21, 2021 15:15:30 GMT -5
MNKD Nasdaq volume at the half day of trade, real time, 363,095 summary, 579,264 4.5360. +0.0560 (+1.25%) As of 12:46PM EDT. Market open. minutes between trades. MNKD nasdaq real time volume, 870,001 (300,000 shares came on end of day) MNKD Nasdaq summary volume, 1,251,168 Avg. Volume 2,941,601 4.58. +0.10 (+2.2321%) As of 4:00PM EDT. Market open. MNKD weekly on a Tuesday.  |
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Post by falconquest on Sept 21, 2021 17:59:39 GMT -5
Stock price is definitely in wait and see what the FDA does mode. Flag comes to a point around Thanksgiving. Sometime soon it will break north or south. That it will. Seem to be differing opinions on when the FDA will give their response ranging from, anytime between now & Oct 15th to anytime between now & Oct 31st to Oct 15th exactly. Would think volume & volatility will kick in once the crowd believes it is getting close. I appreciate the chart folks - can not image how challenging that must be but they too must know the rumors & news will ultimately, drive those charts - which way this time… we should know soon. Zzzzzzz..........zzzzzz...........zzzzzzz |
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Post by bones1026 on Sept 21, 2021 19:30:55 GMT -5
That it will. Seem to be differing opinions on when the FDA will give their response ranging from, anytime between now & Oct 15th to anytime between now & Oct 31st to Oct 15th exactly. Would think volume & volatility will kick in once the crowd believes it is getting close. I appreciate the chart folks - can not image how challenging that must be but they too must know the rumors & news will ultimately, drive those charts - which way this time… we should know soon. Zzzzzzz..........zzzzzz...........zzzzzzz Not sure I get the “zzzzz”..What is it in response to? |
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Post by letitride on Sept 21, 2021 20:16:52 GMT -5
Apparently were going up on the lowest volume in almost a year. Im looking back at 10/15/20.
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Post by peppy on Sept 22, 2021 11:49:09 GMT -5
MNKD Volume at the half day of trade,
real time, 410,169
summary, 649,813
Avg. Volume 2,911,781
4.6500. +0.0700. (+1.5284%)
As of 12:45PM EDT. Market open.
4.6600+0.0800 (+1.7467%)
As of 12:47PM EDT. Market open.
Through 4.66, 4.75.
=================================
Volume low on UTHR as well,
57,281
Avg. Volume 328,835
202.37 +3.54 (+1.78%)
As of 12:43PM EDT. Market open.
We seem to be trading with UTHR.
The biotech sector started the morning negative. With time it became positive.
Money being deployed looks like to me.
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Post by akemp3000 on Sept 22, 2021 12:02:45 GMT -5
With the low volumes being seen, this does not yet have the appearance or attention of a stock heading toward a FDA decision date. Hopefully soon.
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Post by stockwhisperer on Sept 22, 2021 12:13:43 GMT -5
With the low volumes being seen, this does not yet have the appearance or attention of a stock heading toward a FDA decision date. Hopefully soon. It is still early, especially if some folks think it could happen at the end of October. Agree w/the folks that think it will most likely happen, as it typicallly does for all biotechs heading into FDA decisions. GL |
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Post by sweedee79 on Sept 22, 2021 12:46:23 GMT -5
Lqda stock up 10%.. investors yelling about a PDUFA date of Nov 4...
Yet Mnkd trading with low volume ... Makes no sense
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Post by MnkdWASmyRtrmntPlan on Sept 22, 2021 13:11:35 GMT -5
Zzzzzzz..........zzzzzz...........zzzzzzz Not sure I get the “zzzzz”..What is it in response to? bones, I think falcon is just commenting on the consistently sideways movement of the stock-price despite the imminent FDA result/decision (meanwhile we are all waiting for it to head northward). either that or else falcon fell asleep while typing verbally with his microphone ... AGAIN (JK, falcon)  |
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Post by prcgorman2 on Sept 22, 2021 14:24:31 GMT -5
With the low volumes being seen, this does not yet have the appearance or attention of a stock heading toward a FDA decision date. Hopefully soon. It is still early, especially if some folks think it could happen at the end of October. Agree w/the folks that think it will most likely happen, as it typicallly does for all biotechs heading into FDA decisions. GL I’ve kind of assumed most of the bets have already been placed and we’re just waiting. From what I’ve been reading, if there was going to be a CRL, we probably would have seen it already. That’s not a guarantee but simply an observation of past Priority Review Voucher experiences. And it makes sense that UTHR would not have spent north of $100M on a PRV on merely hoping the review would go well. So I think most of the waiting is for confirmation and if that is accomplished then hopefully acquiring more MNKD stock (esp. by institutions) will be less inhibited. It may be that the MNKD share price is drifting up on light volume because shorting is inhibited (or because they’re unconcerned about being able to drive the SP back down at the end of the day or week). |
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Post by akemp3000 on Sept 22, 2021 15:04:08 GMT -5
I agree if a CRL was going to be issued, it would likely have arrived already and this whole process makes sense for UTHR. The assumption that most bets have been placed and we're just waiting is not normal for any biotech approaching a PDUFA date. I've tracked many for years and have never seen stability weeks prior to the announcement. That said, I can't recall tracking one with an expedited voucher so it's possible you're right since an expedited voucher increases the odds there won't be a surprise.
My gut instinct still believes we'll see volatility and big volume prior to the decision. I recall when MNKD was up for a decision and the volatility was big. The morning of the PDUFA date around 10:00 a.m., an unsubstantiated negative rumor hit the wires and the pps immediately plummeted taking out all shares that had stops. Within 30 minutes, the rumor was gone and the pps leaped back up. Those with the stops lost all their shares. They of course were livid and threatened lawsuits but nothing materialized since there was no one to sue for the apparently corrupt rumor without a forensic audit. I certainly can't see this forthcoming decision having that level of volatility though the depths of corruption in today's environment should surprise no one. GL
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