Class I or Class II Delay

[ktim]

Nov 2, 2021 6:44:16 GMT -5 prcgorman2 said:

Nov 1, 2021 16:20:13 GMT -5 ktim said:

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?

Just have a tendency to ridicule what I find... oh, what's the adjective I'm looking for, think it starts with an "r".  Whether a company is public or private I think shareholders deserve information.  Withholding information erodes investors' confidence.  And invariably it is the retail investors that suffer the most, with those "hedge funds" having their own sources and not relying on corporate disclosure as I have to.   The idea of keeping retail investors in the dark as somehow disadvantaging hedge funds and the like I simply don't find credible.  I'm a relatively small time investor, however, not a professor of corporate finance.

BTW, I'm sure any creditors would require as much transparency.

Actually I'm quite the opposite of bitter.  At a very good place in life in general, and more specifically with regard to MNKD I'm very happy about what has been a pretty remarkable recovery.  Can't believe I've gotten to a point where a huge loss has now become a profit.

[prcgorman2]

Nov 3, 2021 10:21:34 GMT -5 ktim said:

Nov 2, 2021 6:44:16 GMT -5 prcgorman2 said:

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?

Just have a tendency to ridicule what I find... oh, what's the adjective I'm looking for, think it starts with an "r".  Whether a company is public or private I think shareholders deserve information.  Withholding information erodes investors' confidence.  And invariably it is the retail investors that suffer the most, with those "hedge funds" having their own sources and not relying on corporate disclosure as I have to.   The idea of keeping retail investors in the dark as somehow disadvantaging hedge funds and the like I simply don't find credible.  I'm a relatively small time investor, however, not a professor of corporate finance.

BTW, I'm sure any creditors would require as much transparency.

Actually I'm quite the opposite of bitter.  At a very good place in life in general, and more specifically with regard to MNKD I'm very happy about what has been a pretty remarkable recovery.  Can't believe I've gotten to a point where a huge loss has now become a profit.

Fair enough.  I sometimes indulge the same tendency.  I have an old friend who used to admonish me about it, iron sharpens iron as the saying goes.

I agree shareholders deserve information, and I think the professor (now probably retired) would agree too.  I think his point was that not enough happens in a typical quarter to warrant the time and cost of an auditable/audited GAAP-compliant balance sheet and revenue statement.  As I said, I wasn’t sure what to make of the opinion other than I thought it was an interesting counter-argument to quarterly reporting.

The negative effect of Sarbanes-Oxley act (and perhaps post-2008 AML regulation) on the US equities market has been advanced by others but it did dovetail with the professor’s argument.  It is a fact the US equities market has shrunk significantly, and I don’t buy corporate greed as the dominant cause.  I am much more inclined to believe smart corporate finance professionals know the cost of capitalizing their company and help make business decisions to minimize it accordingly.  The obvious and publicly discussed result in many cases is stock buy-back programs and taking a company private.

Regardless of the causes, the trend has not been towards more transparency.  So while i agree with you that shareholders deserve information, I’m always skeptical of how much and how often.  I’d rather have the opportunity for ownership in a company, even if it required greater faith in their management, than be relatively locked out of equity securities and relegated to the debt market for the dominant majority of investment options.  There needs to be a reasonable balance, and I’m not sure that exists.

[mytakeonit]

Monthly and quarterly reports are just reading material that shows you what happened. If you don't understand what it is saying and can't decide where the company should be headed ... then it becomes a boring meeting. Having people that understand the reports and know how to react to them ... makes for a very profitable company.

But, that's the accountant in mytakeonit

[winner]

Interesting read.....

So pleased with MNKD's current share price. Onwards and upwards.

www.nydailynews.com/opinion/ny-oped-fda-fails-american-patients-20211109-d2zzig2ounflbgczympfwrtp3u-story.html

[comnkd]

Nov 12, 2021 7:31:16 GMT -5 winner said:

Interesting read.....

So pleased with MNKD's current share price. Onwards and upwards.

www.nydailynews.com/opinion/ny-oped-fda-fails-american-patients-20211109-d2zzig2ounflbgczympfwrtp3u-story.html

Thanks for sharing.

Your body, your choice. Right?

Unless big pharma, I mean the FDA is involved.

[sweedee79]

I'm sure Martine is pulling out all the stops to make sure it's class 1... If not UTHR still has the upper hand right?

I guess we will see as the drama unfolds.. And These Are The Days of Our Lives in Mnkd land....

[mango]

Anyone else notice in that article they mention Receptor Life Sciences BoD member Orrin Devinsky?


With the help of Dr. Orrin Devinsky, now director of NYU Langone’s Comprehensive Epilepsy Center, she identified clobazam. The drug had been available in Europe since 1974. By 2007, it would be available in more than 100 countries. Yet the FDA would not approve it until 2011.

[winner]

Here is another example:

www.cnn.com/2021/09/26/politics/alzheimers-drug-aduhelm-fda-approval/index.html

[akemp3000]

Nov 13, 2021 10:46:38 GMT -5 winner said:

Here is another example:

www.cnn.com/2021/09/26/politics/alzheimers-drug-aduhelm-fda-approval/index.html

Excellent article describing the disgusting politics of the FDA. Troubling that no one is ever held accountable. Shkreli stands out as a somewhat related exception.

[Chris-C]

Nov 13, 2021 11:15:27 GMT -5 akemp3000 said:

Nov 13, 2021 10:46:38 GMT -5 winner said:

Here is another example:

www.cnn.com/2021/09/26/politics/alzheimers-drug-aduhelm-fda-approval/index.html

Excellent article describing the disgusting politics of the FDA. Troubling that no one is ever held accountable. Shkreli stands out as a somewhat related exception.

Speaking of Shkreli, I read where he was again denied a petition for early release. He's in a low security prison, so for all we know he continues to short MNKD through his contacts or girlfriend. The guy is corrupt to the core. Prison time will not reform him. The trouble is, the FDA seems to be easily manipulated by shady characters. The SEC needs to tighten up (as has been said repeatedly on this board.) Shkreli plays his games in pharma "investing" because he knows the FDA and the SEC are easy targets for bad guys. IMHO, of course.

[sayhey24]

Nov 13, 2021 11:15:27 GMT -5 akemp3000 said:

Nov 13, 2021 10:46:38 GMT -5 winner said:

Here is another example:

www.cnn.com/2021/09/26/politics/alzheimers-drug-aduhelm-fda-approval/index.html

Excellent article describing the disgusting politics of the FDA. Troubling that no one is ever held accountable. Shkreli stands out as a somewhat related exception.

I still wonder if Shkreli had some connection to Pete Brown when Peggy was running the FDA.  I will say Pete did pretty well for himself running Renaissance Technologies.

[neil36]

Nov 13, 2021 11:15:27 GMT -5 akemp3000 said:

Nov 13, 2021 10:46:38 GMT -5 winner said:

Here is another example:

www.cnn.com/2021/09/26/politics/alzheimers-drug-aduhelm-fda-approval/index.html

Excellent article describing the disgusting politics of the FDA. Troubling that no one is ever held accountable. Shkreli stands out as a somewhat related exception.

Shkreli was just fined $64 million and banned from the Pharma industry for life

[brianrocco]

Class 1 Response!! Hot off the press:
On October 18, 2021, United Therapeutics Corporation (the Company) issued a press release disclosing that it had received a Complete Response from the U.S. Food and Drug Administration (the FDA) concerning the Company’s new drug application (NDA) for Tyvaso DPI™. On December 27, 2021, the Company disclosed that it had resubmitted the NDA to the FDA. Today, the Company discloses that the FDA has acknowledged acceptance of the NDA for review as a class 1 response with a user fee goal date in February 2022.

[hellodolly]

Jan 18, 2022 7:14:07 GMT -5 brianrocco said:

Class 1 Response!! Hot off the press:
On October 18, 2021, United Therapeutics Corporation (the Company) issued a press release disclosing that it had received a Complete Response from the U.S. Food and Drug Administration (the FDA) concerning the Company’s new drug application (NDA) for Tyvaso DPI™. On December 27, 2021, the Company disclosed that it had resubmitted the NDA to the FDA. Today, the Company discloses that the FDA has acknowledged acceptance of the NDA for review as a class 1 response with a user fee goal date in February 2022.

That's an announcement between fourteen days to 6 weeks (02.01-02.28) from today.  If this was a class II delay, shorts would say that the FDA is taking a look at the validity of the CP and the reason for the longer delay..  Now, since it's only a class I delay, shorts are still saying that the FDA is taking a real hard look at a real possibility this is going to be delayed because of the CP....clowns.  

[akemp3000]

I'll go with Martine's optimism and $100M bet on this one versus the shorts thinking there's a real possibility this is going to be delayed. Let's see what the price action says in response to this announcement. Today should be a good day.