"They have the required regulatory personnel to work with FDA. You do"?? Really? PROVE IT? As of their last 10-Q they listed FOUR employees that I could see. A typical FDA submission is an enormous undertaking- most companies doing it have an entire department (as stated, 40 more employees dedicated to just FDA issues would not be unusual). They would have numerous people with long backgrounds in just FDA regulatory affairs- Ph.Ds an M.D. or two and lots of degreed engineers or bio-med majors or similar who have done a lot of regulatory affairs work- it's a complex world unto itself. Nothing else in industry is similar or can train/prepare you to do FDA regulated work- you must know it/learn it from inside a firm that's already doing it or from Sr people who have yrs of expertise at it. It also takes boat loads of money, time and writing long papers, data being compiled in VERY specific formats and then answering questions/rebuts often taking months for a single round of questions and answers to be resolved. From Forbes magazine, 2012: "Part I: The Rising Cost of Clinical Trials- In 1975, the pharmaceuticals industry spent the equivalent of $100 million in today’s dollars for research and development of the average drug approved by the U.S. Food and Drug Administration, according to the Tufts Center for the Study of Drug Development. By 1987, that figure had tripled, to $300 million. By 2005, this figure had more than quadrupled, to $1.3 billion.
The true amount that companies spend per drug approved is almost certainly even larger today. My Forbes colleague Matthew Herper recently totaled R&D spending from the 12 leading pharmaceutical companies from 1997 to 2011, and found that they had spent $802 billion to gain approval for just 139 drugs: a staggering $5.8 billion per drug. The biggest driver of this phenomenal increase has been the regulatory process governing Phase III clinical trials of new pharmaceuticals on human volunteers. One reason: Phase III clinical trials have become far larger and more complex than they were in the past. From 1999 to 2005, as the Tufts group has shown, the average length of a clinical trial increased by 70 percent; the average number of routine procedures per trial increased by 65 percent; and the average clinical trial staff work burden increased by 67 percent. On top of that, increasingly stringent enrollment criteria and trial protocols resulted in 21 percent fewer volunteers being admitted into trials and 30 percent more enrollees dropping out before completion of the tests."
Do you know how many drug candidates in a pharma/med company pipeline EVER see the light of day to FDA approval? It's like ONE PERCENT. Yep- ONE PERCENT. Of a 100 products in a pipeline, "maybe" ONE will ever actually get FDA approval- you then need an entire sales team and distribution and marketing plan and STAFF to hope it ever gets out to the field and is sold and MAKES MONEY. Let alone the costs to set up the controls, manufacturing, maintenance of an FDA produce- enormous record keeping, batch control tracking, recall processes and quarantine for bad product in place,etc ENORMOUS undertakings- taking 100's of people typically and LOTS of cash. Simple as that. Not exaggerating- just stating well documented FACTS. I've been inside an FDA regulated environment- it's brutal, stringent, paper and people and time consuming and strict- as in the FDA can put you out of business "strict" for simple process controls violations when you're dealing with products that enter a patient's blood stream or internals of their body. FDA sees things based on their "invasive-ness"- as in topical is level 1 (think skin cream), piercing the skin level 2 (a needle device) and oral ingested or entering the blood stream as in putting CELLS IN THE FREAKING HEART AREA as the most stringent. It's a long and brutal road to approval and you keep claiming they are "close" to the "end"- but I see no indication that is even remotely true. They don't have to people, let alone money to even draft or write or compile an FDA submission, let alone deal with the 100 other things that will need to come together once you even attempt to submit- the FDA upon submission is not even guaranteed to even respond to your submission, let alone read it all and respond to you and move it forward- they can reject it for any number of a 100 different reasons. IMO you're attempting to way over simplify what needs to take place to ever hope to reach an FDA approval. Good luck- you're entitled to your opinion. I don't see it as even a remote possibility- that's my 2 cents.
AI
