No panic here. We waited for months for a PR that does not give confidence that anything is on it's way.
What is clear is that HemaXellerate needs more safety data procured from testing in a GLP lab. What is also clear is that despite having submitted the IND for HemaXellerate in Feb 2013 (count the months), only recently has BMSN clarified with FDA that that is still needed. If it took over a year and a half to determine this, all after BMSN had submitted the IND to FDA with at least 2 rounds of Q&A, then we can deduce that we are still months away.
If Koos is honest in saying the need for more safety tests are based on the cellular nature of the drug, then the same protocol will apply to dCellVax. It doesn't make sense to assume dCellVax tests were done in a GLP lab if HemaXellerate was not.
Ergo, we are months away from any news that can prop this stock up regarding the 2 drugs it has been pursuing and concentrating on over the past 2 years.
Panic, no, but look at the facts. For those who are only tying up free money and can wait, they can keep buying. For those of us who invested all the available cash we could free up expecting some return in 2014, that no longer seems to be an option.
