The FDA has requested stability data on the product and more information on the stability-indicating assays. Can anyone offer any insight into the seriousness of this setback? Is this likely just a matter of the FDA wanting more documentation (so just a moderate delay), or is this likely a problem that the FDA has uncovered and is now investigating further (longer delay or worse)?
The government's goal for its third generation anthrax vaccine is that it be stable for 3 years at 35 degrees Celsius and provide protection in fewer than two doses. The current vaccine used by the government requires six doses and must be kept in cold chain storage between 2 and 6 degrees Celsius. So the issue of stability (at the higher temperature) is a key factor. PIP has provided assays showing that SparVax will maintain is potency for that period of time at the higher temperature. The clinical hold revolves around those assays used by PIP to support that claim.
So the issue is not whether the drug works, the issue is whether it still works after sitting around in a stockpile for three years at 35 degrees Celsius. How this will be resolved is anyone's guess. But if/when it is resolved, the government will allow the testing to move forward. Hopefully we'll have some guidance from PIP soon.
Thanx arod! very informative post. How can they address this issue unless they have it stored for 3 years to see if it works at 35 degrees Celsius? when did FDA require the 3 years 35 Celsius litmus test and did PIP perform the testing to meet requirements? I am not a scientist but an investor so pardon my scientifically uneducated questioning.
A very compelling question. I have talked to PIP representative/PR extensively on this subject.
I suggest you call yourself and talk to them as they are very receptive to mature investors who have genuine questions. My take on the several conversations has been a response to the FDA is imminent but they need to provide accurate data put together carefully after further tests. No commitment is given of time frame of when response will be done.