RE:RE:1 day to goI agree with your post. I am suggesting it is fluff being the meeting was PRE IND and premature in regards to commencement date. My point is they have failed to hit previous target dates with current trial and 3rd party peer review. I think management onows the Feb first dosing will not be achieved so they wanted to get something positive released in February as 1st dosing news will not be a reality. It was done to madk the failure again for first dosing news.
They have been planning current AKI phase 2 trial for years and its one delay after another. I agree we want to dose the most suitable patients to achieve the optimal results. I mentioned that yesterday.
I will ask you this. Do you know for a fact they are actively recruiting? I dont but assume yes but at what locations?
Do you even know if they have sites/hospitals signed up. Doctors signed up? You would hope so but possibly not finalized.
There is a very good chance we delay again as they have yet to finalize sites and possibly they have yet to even start recruiting.
My point regarding yesterday news being fluff, has nothing to do with repurposing of the drug. That is great news, its safe on humans but we are looking at potential trial in summer. Do you really believe it will be in the summer of 2024 based on current Phase 2 trial slated for fall of 2023, then Feb 2024 and today being Feb 28, good chance that not happening. Independent 3rd party peer review was due June 2023 we are now 8 months past due and the trial was over 700 days ago.
I have stated many times I am bullish on the science but frustrated with poor communication and execution thats all.
There is lots to be bullish about but anyone who thinks management has not made mistakes is dillisional, everyone is accountable.
TheBearInTheWoods wrote: I imagine you are new to the sector to say that announcing a Pre-IND is fluff news. The company is moving forward after interest with clinical teams on TWO more human trials .... The drug is being manufactured after the FDA lit a green light ahead, I dont understand your train of thought with a repurposed drug already deemed safe by the FDA.
As for the trial, if you want to rush out to get patients, you risk recruiting patients more likely not being a good fit for the trial.
Management has dropped the ball .... after securing three pathways to drug approval with no dilution, once again interesting outlook.