May 13, 2010

Double, double toil and trouble; Fire burn, and cauldron bubble.

Like the witches of Macbeth, Cellestis shareholders (some) periodically gather to grumble eg
We are now at about the 9th anniversary of CST listing and I have held since then. I no longer have any huge expectations for this stock but will not sell simply because I have held for so long. No one could have expected the resistance to move away from TST to be as strong as it is. IMO the next two profit reports will be critical in determining if CST is ever going to reach its full potential.
Thankfully reason prevails
I think it simplistic to suggest that the last 9 years have all been about moving from TST to Quantiferon;
I would rather say that the past 9 years have been one long marketing exercise, with the product marketed being the QFT-CMI. Specifically regarding TB, the QFT-TB was approved and launched and whilst it held many benefits they proved not sufficient to generate meaningful sales. So the ppd was replaced with two TB specific antigens in QFT-TB Gold, approval was obtained and whilst sales improved the time constraint for processing proved to be a negative. Further refinements were made; the process time was extended and antigens precoated in provided tubes and QFT-GIT was introduced and approval obtained.

A major factor in this process has been the time taken to obtain approvals. No point in complaining about it, it is a fact of life and affects all health industry participants. However, delay is not all bad - it has allowed sufficient time for many independent studies to be undertaken and these studies present a strong argument for further approvals and guidelines and also act as a powerful marketing tool. In addition the delays have added value to those approvals and could act as a disincentive to any future competitors, should there be any.

It must be pointed out that the testing, trialling and subsequent analysis have been undertaken by bodies independent of the company and at no cost to the company.

In addition the lengthy approval process has the effect of increasing the protection of the intellectual property.

When considering the size and complexity of the global TB industry it could be said that for Cellestis the last 9 years have been one of submitting and gaining approvals.

Importantly, whilst the testing and approval process has been underway the sales have been sufficient to make the company profitable. Only now has QFT-GIT been approved for sale around the world (lets not talk about the CDC) and only now can sales be properly generated.

Incidentally, a medical specialist friend of mine was recently telling me of a medical presentation he had attended where the subject was an 8 year old girl. He says that the clinician said
and we did a Quantiferon
This was significant, they didn't say that they were testing for TB or that they were going to use a new blood test or interferon gamma assay; just the word "Quantiferon" was sufficient to convey the message. For me that represents a "tipping point"