I am as frustrated and annoyed as every other TRUE long on this board. The company does not seem interested at this point in providing any news/updates. I believe the next update that we get, will in all likelihood be the submission of the PMA. Previous updates provided timelines that were not met. I believe that the company was utilizing two different facilities, one to manufacture the product and the other to package it for eventual sale. Obviously they encountered problems with either or both facilities. Unlike other posters, with an extreme amount of vitriol no matter what the company does, I am entrenched in this investment to the end. This management team leaves a lot to be desired, and missing timelines, that they themselves imposed on themselves, only hastens the lack of confidence in the company's management team. This is a long, convoluted narrative as to how we got here. Starting with their, "CONSULTANT," who has advised this company from one bad decision after another. Moving the manufacturing facility from China to the United States due to covid concerns, screwed everything up. They left China without having secured a new facility, a quintessential element of FDA PMA approval. Then, they were advised to run only one batch of product before submitting the PMA approval again, which was summarily panned by the FDA. Then we get updates, new updates about the previous updates, all to no avail. My other concern is that due to all of this wasted time, does the entire 180 day FDA approval start all over again? I have no idea.
With all of that being said, I am here for the Hemostyp product. I believe in it, but i do not believe in this management team. The greatest thing that can happen here is a buyout or partnership with a deep pocketed company that can assist in getting this approved, manufactured and distributed. But, with the situation we are in now, any buyout/partnership would be worth significantly less than what we would have gotten a year or two earlier.
Those are my thoughts.
