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Post by cppoly on Mar 19, 2024 7:56:29 GMT -5
Per the last quarterly call, there's three more milestones expected to happen in the first quarter of 2024:
1) MNKD-101 IND expected to be filed
2) MNKD-201 IND expected to be filed
3) Tyvaso DPI high speed fill finish line
So we have less than two weeks left. Hopefully these are noteworthy press releases and this information is shared with everyone.
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Post by cretin11 on Mar 19, 2024 8:06:37 GMT -5
PRs to be released this week hopefully, but if not then next week.
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Post by prcgorman2 on Mar 19, 2024 9:11:03 GMT -5
Is an IND filing press-worthy?
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Post by cretin11 on Mar 19, 2024 9:56:46 GMT -5
Yes IMO
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Post by Clement on Mar 19, 2024 11:09:10 GMT -5
Alternately, we might have to wait 7 weeks to hear about it on the Q1 EC.
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Post by prcgorman2 on Mar 19, 2024 11:12:36 GMT -5
Fair. It seems important to you, so it is reasonable you would want that. For kicks, I did a Google search using the phrase, "filed a new IND with the FDA". Interestingly, I didn't see a single hit for any drug company where that phrase was used, and in fact, all of the 2 dozen or so hits that I looked at from the top were describing what an IND was. No announcements. Other searches would probably turn up something, but as far as the Google search algorithm was concerned, the phrase I chose to see new IND filings, turned up bupkis. It isn't definitive of course. I'm sure some new IND filings get published. But in general, I'm guessing new IND filings aren't necessarily very news worthy. Doesn't matter to me though. If you would like to see a blurb, I would too. |
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Post by cretin11 on Mar 19, 2024 11:22:12 GMT -5
It's really not a big deal to me, "important" is stretching it though i can see why my posts gave you that impression. For me it's a simple analysis: we don't hear much from our company in between quarterly calls, if there is an opportunity to get good PR out into the investment community I'm in favor of it. We apparently have employees responsible for such matters, it doesn't seem like a big ask of them.
On the other hand, if such a PR release would be deemed as ridicule worthy for the reason you suggest (because nobody does it hence it would be a bush league move), then my opinion would flip to a no. I'm not knowledgeable enough to know which it is. If the truth is somewhere in between, then i default to getting some positive news out there because "why not?" and we don't hear enough about what our folks are doing.
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Post by mayday on Mar 19, 2024 11:54:41 GMT -5
It's really not a big deal to me, "important" is stretching it though i can see why my posts gave you that impression. For me it's a simple analysis: we don't hear much from our company in between quarterly calls, if there is an opportunity to get good PR out into the investment community I'm in favor of it. We apparently have employees responsible for such matters, it doesn't seem like a big ask of them. On the other hand, if such a PR release would be deemed as ridicule worthy for the reason you suggest (because nobody does it hence it would be a bush league move), then my opinion would flip to a no. I'm not knowledgeable enough to know which it is. If the truth is somewhere in between, then i default to getting some positive news out there because "why not?" and we don't hear enough about what our folks are doing. You are definitely on some one's crap list. lol |
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Post by prcgorman2 on Mar 19, 2024 12:25:19 GMT -5
It's really not a big deal to me, "important" is stretching it though i can see why my posts gave you that impression. For me it's a simple analysis: we don't hear much from our company in between quarterly calls, if there is an opportunity to get good PR out into the investment community I'm in favor of it. We apparently have employees responsible for such matters, it doesn't seem like a big ask of them. On the other hand, if such a PR release would be deemed as ridicule worthy for the reason you suggest (because nobody does it hence it would be a bush league move), then my opinion would flip to a no. I'm not knowledgeable enough to know which it is. If the truth is somewhere in between, then i default to getting some positive news out there because "why not?" and we don't hear enough about what our folks are doing. You are definitely on some one's crap list. lol Everyone who is anyone is on someone's.  |
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Post by hellodolly on Mar 19, 2024 15:10:06 GMT -5
Fair. It seems important to you, so it is reasonable you would want that. For kicks, I did a Google search using the phrase, "filed a new IND with the FDA". Interestingly, I didn't see a single hit for any drug company where that phrase was used, and in fact, all of the 2 dozen or so hits that I looked at from the top were describing what an IND was. No announcements. Other searches would probably turn up something, but as far as the Google search algorithm was concerned, the phrase I chose to see new IND filings, turned up bupkis. It isn't definitive of course. I'm sure some new IND filings get published. But in general, I'm guessing new IND filings aren't necessarily very news worthy. Doesn't matter to me though. If you would like to see a blurb, I would too. ABCL (NP) - ABCL 2/22/24 Up on the news, drifting down since. AbCellera upgraded to Buy at Benchmark after R&D progress As previously reported, Benchmark upgraded AbCellera to Buy from Hold with a $9 price target. AbCellera reported results for Q4 and highlights during the fourth quarter included three new partnered program starts, two proprietary R&D programs entering into IND-enabling studies, and three additional partnered molecules entering clinical trials, the analyst tells investors. The firm's post-earnings upgrade is due to improved metrics for other stocks as well as R&D progress for the company, the analyst noted. VERU (NP) - VERU 2/6/24 Down for a week on the news and then a reversal up, since. Veru Announces FDA Clearance of IND Application to Initiate Phase 2b Clinical Trial with Enobosarm to Treat Muscle Loss Associated with Weight Loss Drugs(Globe Newswire) KTTA (NP) - KTTA Up on the news, drifting sideways. SOUTH SAN FRANCISCO, Calif. and MIAMI, Jan. 02, 2024 (GLOBE NEWSWIRE) -- Pasithea Therapeutics Corp. (NASDAQ: KTTA) (“Pasithea” or the “Company”), a biotechnology company focused on the discovery, research, and development of innovative treatments for Central Nervous System (CNS) disorders, today announced the Investigational New Drug Application (IND) clearance to proceed by the U.S. Federal Drug Administration (FDA) to evaluate PAS-004, a macrocyclic MEK (1/2) inhibitor, in patients with MAPK pathway driven advanced solid tumors with a documented RAS, RAF or NF1 mutation or patients who have failed BRAF/MEK inhibition. Pasithea expects to dose the first patient in the first quarter of 2024. |
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Post by Thundersnow on Mar 19, 2024 15:33:57 GMT -5
Is an IND filing press-worthy? MOST DEFINITELY! |
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Post by sayhey24 on Mar 19, 2024 17:58:03 GMT -5
Unless Mike expands his thinking I think the next worthy PR will be Inhale-3 updates for ADA2024 which is not until June 21.
I watched the Oprah special last night. There was a 16yr girl using Victoza since its the only FDA approved GLP1 for the kids. I think a PR announcing a pilot study on Saxenda DPI would be PR worthy.
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