Tuesday, March 02, 2021 12:53:47 PM
FDA says they want more info from manufacturer and a manual study to make sure right amount of defencath is extracted from viles. Without a CC we are left to guess what that means. My assumption is the manufacturer didn't provide a strong enough case that their control procedures are in place to ensure proper vile fill up. So FDA says prove you are putting the right amount in each vile and then prove there is a back up by ensuring the proper amount is extracted for use so we are sure the manufacturer isn't shorting or overfilling viles.
Just my guess.
My thoughts:
1. Easy fix for sure
2. Easy doesn't mean quick. It takes 45 days just to schedule a meeting.
3. That April meeting is REALLY important. There is a chance CRMD will need to remedy the issues and then file a new NDA. This is worst case scenario. That get us to Q4 2021 / Q1 2022.
4. Best case is Q3 2021. Without a whole new NDA filing.
5. Capitol Raise..... probably not, but they really like that ATM. IF a new NDA is needed, that is bad! They would need money. This is where investors struggle. When a company says they have enough money for 1 year, they need to raise pretty quick. Can't run the bank account to zero.
4. I am figuring in about a 10% dilution now into my own spreadsheet I keep by Q1 2022.
5. The bulls have had control of the price the past few weeks, now control appears to be with day traders. If control move to bears, look out.
6. $8-9 is a good buy in my opinion, but would not be surprised if it goes down more.
7. I am thinking short term (1-6) month bear case and long term bull case as of this minute. CRMD management can change my opinion with a simple conference call.....but the lack of a call signals a lack of a plan.
8. Then again, I could be full of crap and they fix everything in 2 months and we are off to the races......this would be fantastic! Still long, will buy more at some point.
Final note from me:. Really disappointed with the company. They took their time with the excuse of crossing all t's and dotting all I's yet here we are. These are my opinions only.
Recent CRMD News
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 08/14/2024 12:15:30 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 08/14/2024 12:00:13 PM
- CorMedix Inc. Receives FDA Feedback on Potential Label Expansion • GlobeNewswire Inc. • 06/18/2024 12:00:00 PM
- CorMedix Inc. Announces CMS Grants Pass-Through Status to Defencath • GlobeNewswire Inc. • 06/06/2024 12:30:00 PM
- Form EFFECT - Notice of Effectiveness • Edgar (US Regulatory) • 05/23/2024 04:15:06 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 05/13/2024 08:22:51 PM
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- Form 8-K - Current report • Edgar (US Regulatory) • 05/09/2024 11:40:17 AM
- CorMedix Inc. Announces CMS Grants TDAPA to DefenCath • GlobeNewswire Inc. • 04/19/2024 12:30:00 PM
- CorMedix Inc. Announces U.S. Inpatient Commercial Availability of DefenCath® (Taurolidine and Heparin) • GlobeNewswire Inc. • 04/15/2024 12:30:00 PM
- CorMedix Inc. Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Business Update • GlobeNewswire Inc. • 03/12/2024 11:30:00 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 01/30/2024 10:26:20 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/18/2024 01:11:54 AM
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- Form 8-K - Current report • Edgar (US Regulatory) • 10/30/2023 08:35:11 PM
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