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Post by avi8torslc on Nov 1, 2021 10:56:16 GMT -5
Hope some color is provided tomorrow on how long of a delay with the CRL. 2 months if it’s a Class I
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Post by MnkdWASmyRtrmntPlan on Nov 1, 2021 12:47:20 GMT -5
If the CRL is classified as a Class 2, CDER will complete the review and act on the application within 6 months of the receipt date
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Post by avi8torslc on Nov 1, 2021 14:41:54 GMT -5
And a Class I, short 2 months
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Post by hellodolly on Nov 1, 2021 14:44:57 GMT -5
I hope we hear NOTHING! Shorts need this sort of information to time their trades..thrive on entering and exiting data ahead of events. I'd rather they squirm and not have anything to help the short play and they get caught in a squeeze. Just saying.
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Post by ktim on Nov 1, 2021 16:20:13 GMT -5
Definitely... SEC should just do away with requirement for any transparency. Gotta hurt those shorts. I'd feel so much better knowing everything is kept secret. Investing needs to be more based on faith. Information just serves to tear down that. Too many shareholders think of themselves as part owners of a company and that they are owed something.
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Post by golfeveryday on Nov 1, 2021 16:54:32 GMT -5
And a Class I, short 2 months hope it’s 2 months as well but they have to get everything set up internally, then FDA inspected, then submit for review? Even Class 1 will be until Q1 sometime? |
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Post by prcgorman2 on Nov 2, 2021 6:44:16 GMT -5
Definitely... SEC should just do away with requirement for any transparency. Gotta hurt those shorts. I'd feel so much better knowing everything is kept secret. Investing needs to be more based on faith. Information just serves to tear down that. Too many shareholders think of themselves as part owners of a company and that they are owed something. The professor I had for a master’s class in Corporate Finance argued that quarterly reporting was harming corporations because it caused needless volatility because the horizon for material change was beyond 3 months. He advocated that 6 months or even a year would be better reporting mileposts. I thought it was an interesting opinion. I don’t know if it was formed based on studies, or what, so I didn’t know what to think of it but always thought it was interesting because it is not the norm. I will generalize that he thought of the US securities market as being a good thing insofar as it helped capitalize startups and foster innovation which the US has a well established reputation for, but that smart money management would focus on debt capitalization because the cost of debt is less than the cost of equity. Shareholders ultimately demand dividends of mature companies. He mentioned more than once that old equity markets in Europe and Asia were far smaller as compared to the US because old established companies were often privately held and relied on debt financing. If you look at the history of the US equity market over the last 30 to 40 years what you will notice is that it shrank dramatically. I’ve seen certain political idiots claim it is because of corporate greed, but I am more inclined to believe Sarbanes-Oxley and the rise of hedge funds (and shorting) led to the decline. Also, I notice you favor sarcasm. You’ve written some very good posts in the past without it. Why so bitter these days? |
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Post by Clement on Nov 2, 2021 7:22:33 GMT -5
Remember what Martine already told us. Summer or earlier. That looks more like 6 months rather than 2 months.
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Post by akemp3000 on Nov 2, 2021 9:01:02 GMT -5
Maybe Martine will provide the answer, or at least a hint, at their 3Q call tomorrow?
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Post by avi8torslc on Nov 2, 2021 11:28:34 GMT -5
Knowing her style, that was a worse case. Hopefully some color on Quarterly call…
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Post by peppy on Nov 2, 2021 11:33:50 GMT -5
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Post by mytakeonit on Nov 2, 2021 13:26:55 GMT -5
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Post by kite on Nov 3, 2021 8:20:28 GMT -5
I love how this question (Class I or Class II?) was answered on the call. Keeps everyone on the edge of their seat!
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Post by cppoly on Nov 3, 2021 8:23:30 GMT -5
I love how this question (Class I or Class II?) was answered on the call. Keeps everyone on the edge of their seat! They said they are very confident in approval AND they can address this "ONE" issue. |
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Post by Clement on Nov 3, 2021 8:26:03 GMT -5
I love how this question (Class I or Class II?) was answered on the call. Keeps everyone on the edge of their seat! For those who missed the call, Dr Peterson answered by saying that UTHR will have meetings with FDA on this question and that UTHR is confident of approval by summer or earlier. |
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