Replies to post #827 on CorMedix Inc (CRMD)

[Lazerking40]

I am always a big fan of being an active investor. I am sure they either have met or have scheduled to meet with the FDA on an approval route. I also think it is a good bet that the FDA will agree with DSMB to halt the trial. The bigger issue is if they will allow the NDA now or require another phase 3. Obviously, it would be in our short term interest, and long term to be quite honest, if they can go straight to market; however, I think more info will be required by the FDA than just the 28 events from this phase 3 interum analysis. WIth that, I think the meeting will be a little more complicated. Obviously they will use the results of the trial, but I think some of the discussions may be about utilizing other information as cross reference info to go along with the Phae 3 such as prior trials, current success and number of events from European use, etc. So, while it seems like a slam dunk, and I think it is at least a lay up, I also believe that there is some red tape to get through to ensure FDA is cmfortable allowing the NDA. The next shareholder meeting will be an exciting time and I think will reveal a lot. Financing plans, CRO negotiations, and what plan has been agreed upon between FDA and CRMD. It would be awesome, I agree, to get a PR with the plan ahead of time, but if nothing else, we have less than 2 weeks before we get at least some insight as to what the plan going forward is. Financing the company both near and long term is also a big issue, but as bad as CRMD has been in the past with raising capital, they have shown to be extremely shareholder friendly running on empty for about a year now. While this is good for dillution and shareholders, it has put us in a little pickle with AMEX compliance. I think the positive news has opened the door to many options for the company now, and whichever option they choose will be almost as important as the FDA approval. There has been a clear change in direction since last summer to be shareholder friendly, and I think that will continue in my honest opinion.

Let us know if you hear something back and good luck to you!