It's one thing if BMSN stated they received the FDA letter and needed until Q3 to answer all the questions. That would indicate that those issues are major hurdles and the company is unsure how to address them. From the PR, they are still awaiting the letter with the questions. They filed in February and didn't get an IND number until weeks later and still no letter detailing the issues from FDA. I think they realize better than us the kind of speed the FDA moves with and wanted to give a conservative estimate. They also feel they have a better handle on the process and issued a much more expedient timeline with the Min technology. By the end of this year they will have 2 products in clinical trials that can potentially pave the way for so many different indications : not just aplastic anemia, but all bone marrow problems and not just metastatic Brest cancer , but other forms of cancer as well. Their strategy is genius. Go after unmet, life threatening disease to speed up the process with orphan status, to quickly get proof of concept. Because their programs have broad implications, they can re-use the same data to file for different indications. Before you know it, their 2 programs is the start of a pipeline of treatments for numerous diseases that is huge in market value and all BMSN has to do is get a small piece of the pie. If their products work ( that's a big IF), they will easily capture market share, considering the current treatments for bone marrow disorders and certain cancers are more costly and less effective. This a huge risk folks, but well worth it. IMHO
AI
