There's been a lot of hair-splitting over the calculation of 80 days, 100 days, 180 days etc regarding FDA notifications. But is this missing the big picture?
It is far more relevant to be better informed as to why the FDA paused the approval process and what is required of AVH in order to get RECELL GO approved.
I picked up the quotes below from
@saltland 's post on the other thread:
"The longer aspect of the delay is required cell suspension testing. It is Wilsons' understanding that the FDA requires further samples to better validate statistical significance between RECELL GO and the original RECELL device." Wilsons
"The main cause of the delay is time needed for a different method of statistical analysis to compare suspended skin cells from the automated process (Recell Go) and the current method of using Recell (manual disaggregation)". Morgans
Those are actually quite different "understandings" of what has caused the delay and therefore what might be required for AVH to proceed.
It is totally unacceptable that the company has made no announcement regarding the FDA issue. I agree with
@ThaLuvDocta that AVH should publish the FDA letter along with an explanation regarding what it intends to do the address the FDA issue.
Obviously, the brokers above have been in touch with the company, but either the company has given mixed messages, or people at AVH are having problems interpreting what the FDA wants, or the brokers are having trouble understanding what AVH is telling them.
It's the single most price-sensitive issue AVH has faced in the past two years and (leaving aside the farcical decision to mark the 8-K announcement as non-price-sensitive) the company continues to leave it unaddressed. Its had more than enough time to consider the contents of the notification and make a comprehensive announcement and its obviously been prepared to have chats about it with brokers, so continuing to fail to inform the market is a disgrace.
We all know what markets think about uncertainty. We also know about the unfortunate behaviour of Boards and Management in trying to minimise the significance of bad news. The ongoing silence from AVH just plays into this and we're starting to see share price action in accordance.
Adding "lack of confidence in management" and "lack of transparency" to the RECELL GO delay is totally unnecessary and strike one against the current CEO.
(20min delay)