Afrezza in Australia?

[mnholdem]

Fiasp was just approved by the Australian drug regulatory authority.

FIASP, FIASP FLEXTOUCH, FIASP PENFILL
Evaluation commenced: 1 Apr 2019
Registration decision: 11 Mar 2020
Date registered: 13 Mar 2020
Approval time: 190 working days (255)

Source: www.tga.gov.au/prescription-medicines-new-or-extended-uses-registered-medicines

Unlike ClinicalTrials.gov in the USA, Australia apparently doesn’t publish drug applications until after rendering its decision.

When did AMSL Diabetes register Afrezza in Australia? We don’t know when (or if) they have and there is no mention of Afrezza on the AMSL Diabetes website since the partnership announcement in May 2019..

www.amsl.com.au/newsandevents/amsl-diabetes-partner-with-mannkind-corporation/

[mnholdem]

Note: The MannKind-AMSL partnership was signed one month after evaluating commenced for Fiasp insulin (Novo Nordisk). My point is that, based upon the average timeline of Australia authorities to render drug approval decisions, MannKind stockholders may hear news soon.

Of course, we do not know the date of registration of Afrezza by AMSL. Was Afrezza registered immediately or was it delayed. I would think that CEO Castagna knows the answer.

Is this privileged information that cannot be shared with stockholders?

[yash]

I saw post from Kevin in ST and he raised a very valid question that why AMSL is not mentioned as partner in addition to UTHR and CIPLA in the new site.

[goyocafe]

Apr 28, 2020 7:06:08 GMT -5 yash said:

I saw post from Kevin in ST and he raised a very valid question that why AMSL is not mentioned as partner in addition to UTHR and CIPLA in the new site.

I saw that. Imagine if it’s another ghost partnership up in smoke, and shareholders are left to decipher the information without any input from the company. Please tell me this won’t or didn’t already happen!

[itellthefuture777]

Afrezza is the best there is..everyone knows...faster in and out with superior glycemic controls..and lower hypo risk..

[mango]

Apr 28, 2020 7:14:45 GMT -5 goyocafe said:

Apr 28, 2020 7:06:08 GMT -5 yash said:

I saw post from Kevin in ST and he raised a very valid question that why AMSL is not mentioned as partner in addition to UTHR and CIPLA in the new site.

I saw that. Imagine if it’s another ghost partnership up in smoke, and shareholders are left to decipher the information without any input from the company. Please tell me this won’t or didn’t already happen!

Simplest thing to do would be to email IR and ask. 

[falconquest]

Apr 28, 2020 6:37:33 GMT -5 mnholdem said:

Note: The MannKind-AMSL partnership was signed one month after evaluating commenced for Fiasp insulin (Novo Nordisk). My point is that, based upon the average timeline of Australia authorities to render drug approval decisions, MannKind stockholders may hear news soon.

Of course, we do not know the date of registration of Afrezza by AMSL. Was Afrezza registered immediately or was it delayed. I would think that CEO Castagna knows the answer.

Is this privileged information that cannot be shared with stockholders?

Isn't this material information?

[mnholdem]

I don’t believe so. You may recall that the original Agreement between MannKind and Biomm SA (filed with the SEC as an attachment) stated that financial terms would be determined only if Afrezza received approval by the Brazilian drug approval agency ANVISA.

After Afrezza received that approval, I contacted MannKind’s legal counsel to ask whether those financial terms would be disclosed to shareholders. To paraphrase his response, the company does not consider the financial terms to be material news. Of course, I disagreed but I suspect that General Counsel Thomson knows the SEC requirements of what constitutes a material event.

I do admit that I nearly filed a grievance with the SEC.