GVHD the first step, page-92

Well at least he attempts an in depth analysis based around the facts that have been disclosed.

Its way better than the personal attacks and sniping from people who have blind faith and make no effort to discern what's going in anything approaching a realistic appraisal of facts.

But the facts are these:

1. The company received a CRL on their first submission of the BLA
2. The company's description of the control group in the aGVHD wasn't accurate and as the result, the FDA didn't accept the single arm trial result as valid.
3. The company said it would resubmit the BLA addressing all the problems raised by the FDA 2 years ago. It hasn't done so yet.
4. The company is accused of misleading investors about the quality of the trial results and prospects for approval in multiple class action law suits in the USA and Australia. Most are still in progress and one was settled out of court for $2m.
5. It was leaked by one of the company's officers that they had problems with the new potency assay they were going to submit to the FDA, and they have had to revert to the original one.
6. The company has further said it has to rely on the "totality of the evidence" in the hope of persuading the FDA to give limited approval.
7. $30m of the funds the company says are available credit will cease to exist in a week or so as the funding agreement expires on Dec 31.
8. The company loses around $80-$100m every year and needs to keep around $60m in available cash to meet loan covenants and operating expenses. By early next year they will probably need to address funding.
9. Major partners/investors such as TEVA and Novartis have walked away
10. Every major trial the company has been involved with has failed to achieve the primary end points.

It's just hard to find anything that would give investors a real chance to get their money back. The only thing in its favour is the loyalty of a small hard core of faithful investors hoping to redeem their losses. The company's track record of actual achievement doesn't give any real cause for comfort.