Brown,
Some excellent comments there. Certainly one of the better more negative posts made here. I agree with gsw - good to see, for a change, a negative comment with, unlike the usual one-liner drivel, some intellectual substance.
While I agree with some of what you say, I disagree with much of it. Below, I have extracted quotes from your post and given my responses to those
1. "My take on SBN, it will take 12 months b4 anything starts to happen, because that's about how long it will take for FDA approval"
It may take this long – but this won’t be clear until SBN management have met with FDA to hammer out agreed requirements. I believe there is also a chance that SBN could get approval (as it does with its urine-based devices) to market and sell Oraline into the large workplace markets (which it can’t do at the moment) pending FDA assessment. This would be at least 50% as good as clearance with still the possibility of clearance to come.
2. "They basically admitted themselves that FDA approval was the most important item on their agenda by saying that all available resources would be put towards that goal".
Indeed, that was certainly true up to the 12 December, last year. Since than, with the signing of the alliance with SiYi, the Chinese market potential is seen by the company (and at least some shareholders) to have at least the same level of company making potential (not that the company has yet articulated this properly – but it will soon).
3. "If China, Russia and Mexico were just as significant (or more so if you believe some posters on this forum) than FDA approval then why wouldn't they have been focusing on them and just let the FDA approval bubble away".
My understanding is that China and Russia have been focused on just as much as the FDA submission. In fact, Andrew Paice ran with the China project while Brian Andrews focused on the USA and FDA in particular.
Mexico is probably on the back burner - not because of its lesser importance but because of the stuffing around by multiple government agencies in Mexico. It is likely to happen, but much later than originally anticipated.
The Russian prospect has similar regulatory issues – but hopefully we will hear soon how this is going.
China –this is just a matter of waiting for internal Chinese approval processes to take their course. Hopefully, in this Olympic year the process will be expedited and we may get final approvals and production start up earlier than the anticipated mid-year time line.
4. "For Christ's sake how long can negotiations with China and Russia be at advanced stages for. Have these fallen through and they haven't told us?"
The China negotiations passed through the ‘advance stage’ in early December last year. They are complete. We are now just waiting for government approvals.
Russia – I agree. It’s been far too long. I want to hear the story. Don’t believe it’s fallen through but I want to see it over the line.
5. "FDA approval was the only thing that could propel this company onto bigger and better things"
I don’t agree with this. FDA clearance will be big – when it comes – but I believe China will be bigger. The potential figures are huge.
6. "management are incompetent"
In my view, management are generally competent. But not in the area of communications and investor relations. I agree with the comments about the amateurism regarding the web site and the quality of other communications, lack of updates etc. I (and others) have been in contact with the company at board and management level – and I am certain that they will be addressing this in the near term.
To a large extent this reflects the very lean current staffing – with only 3 non-factory personnel (and only 2 before October). The focus has been on product development, distribution and government agency negotiations. Communication has not been the strong suit. They know this and I am sure it will improve soon
7. "Now all the posters who were saying the FDA 510(k) approval was a no brainer and just a rubber stamp, want you to hang in there for the long term."
Doesn’t worry me either way. Each to his own. If I can provide info or insights, based on my research, that help some in making their decision to stay or go, well that’s enough for me/
8. "They were wrong the first time so why trust them?"
I personally confess to being wrong on the FDA clearance – totally wrong. In hindsight, I was too sanguine about the height of the hurdles. I ‘bought’ the story that FDA was in a compromised position – by pulling Oraline off the market, but not its competitors – and would need to expedite the approval process and would look ‘favourably’ on the application.
This didn’t happen. It appears that the FDA are a much tougher nut to crack and, as we all know, many bureaucrats (especially those with small d1cks) feel the need to throw their weight around, demonstrate their power and importance etc.
I haven’t been proven wrong on anything else yet.
I’ll continue to offer both facts and opinions as I see them – as someone interested in the future of the company. Doesn’t really worry me if people trust me or not. It’s up to them.
Brown,Some excellent comments there. Certainly one of the better...
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