Hi Roger10,I am finally back in ACL after a long absence.It...

Hi Roger10,

I am finally back in ACL after a long absence.

It seems to me that the obvious concern for all investors is, has the phase 3 trial met its primary end point. Most posters seem to think it has.

If it has, what is holding the market back?

It may well be that the FDA will procrastinate for significant time before granting approval and that maybe what is spooking the market at the moment.

Southern Cross equities way back in 2011 stated that:

"* Only one trial will be required for US approval - a pre-IND meeting with the FDA in early 2008 established that a single pivotal clinical trial would be sufficient;

* European approval can be gained with the same trial – Alchemia has had guidance from the EMEA to that end; …..

• Both agencies have accepted progression-free survival as the primary endpoint, which is quicker than having to wait to measure overall survival;

• Alchemia will be filing for US approval along the so-called '505(b)(2)' route. With 505(b)(2), the FDA can rely on previous findings of safety and effectiveness for an already approved drug rather than requiring them of the applicant. This notionally makes the review process faster and cheaper."

So if we assume that the phase 111 trial has met its primary endpoint, a process will then involve an application to the FDA, a review and hopefully approval. The time frame for this process is as far as I am aware, unknown.

Like all holders, I am nervous but believe that the next 12 months will be a most exciting time for holders. Especially as the commercialisation/partnering process ramps up

all IMHO.

cheers
Mulac1