My Quick call with Joe Noel (12/3/2009)

After an uncomfortably long two week silence with no updates from BIEL or Joe Noel, I thought I will try to reach out to him. This is the first time I ever called him; I called him during business hours and wasn’t surprised that it went to his voicemail (as my personal phone does too). His VM said to either email him or text him. I had emailed him earlier but hadn’t got any replies, so decided to text him.

He replied back around 5 PM CST and asked me to call him. I called him. It wasn’t a long conversation. Joe was courteous and to the point. Didn’t beat around the bush at all. I asked him only few questions and I don’t remember the exact details but here is what I remember (I am not quoting either my words or his answers since there is no way I can remember exact words exchanged in the conversation.

Q: What is happening with BIEL. There are no updates to shareholders, feels like a dead zone these days.
A: We are going through a lull period. As you know BIEL is a small company and we are trying really really hard to meet all the paperwork requirements as requested by the FDA during our recent meeting.
Q: By the way why were there no updates to shareholders about the two recent FDA meetings?
A: There was only one FDA meeting and it was very short and quick. All they did was give us guidance on any additional paperwork they required for the re-classification.

Q: There are FDA dates floating around in websites like Biomedreports.com, Favstocks.com etc for BIEL FDA Approval. Is there any truth to these dates?
A: You must know that FDA doesnt really give an exact date. It is good that they are working with us and guiding us so that we can achieve what we are trying to do. The most important thing for BIEL is re-classification from class-III to class-II. We don’t want our product to be prescribed by doctors to their patients. We want OTC clearance, so that we can place it on the store shelves (Walmart, Walgreens etc). FDA is scrutinizing our application very carefully, since this is a big deal. That is why they want all paperwork exactly like they want it.

Q: If we can’t put a date on FDA, what is on the horizon in terms of good news for shareholders ?
A: We are working on international sales aggressively. Germany has given us great feedback. There is a meeting soon (I think he said next week) with a Japanese distributor also. As far as good news is concerned, the actual start of DRTV campaign is the next good thing we should expect to hear (approx around 10th December)

Q: When is the Audit going to be completed ?
A: The Audit had a delayed start. It started near Oct End. And it takes approx. 2 months. It is still ongoing as of now. I have a meeting with Andrew in New York (I think he said next week), to discuss this.

So, this is the gist of what I talked to him. I have put all his answers in my words. Definitely not quoting him. But he did tell me “feel free to put all of this on your blog”.

Overall, I feel good after talking to him. It is great that the company has refused to be held hostage to FDA APPROVAL, and has gone ahead with their marketing plans across the world. After all, US is only a part of the equation. They have such good response from countries all over the world. So, they did what they should have done. Go ahead and start marketing in other countries. Fda will come when Fda will come. And then they will just start marketing here as well.

Several people have mentioned on the yahoo boards that with some companies FDA approval led to a decline in the stock PPS, because FDA approval doesn’t mean anything if you don’t have the muscle or means to market your product in the end.