Avid Bioservices Inc (CDMO)

[EYEBUYSTOX]

How bavi gets to market ASAP:

With so many terms being thrown around it's confusing what could actually get bavi into 2nd line NSCLC patients' hands fastest. I think I have the answer: Expanded access to investigational new drugs for treatment use.

While I still believe breakthrough therapy designation will apply and be granted to help speed the full marketing approval here's what I believe could be happening now...

In May 2013, the FDA issued guidance on "Expanded access to investigational new drugs for treatment use". A noticeable coincidence that it happens to be the same month PPHM had their EOP2 meeting.

It explains when a company could expand an IND for commercial use.

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM351261.pdf

I'll do my best to summarize the fun parts.

CFR 312.320 states:

Under this section, FDA may permit an investigational drug to be used for widespread treatment use if...

2)Marketing status . The sponsor is actively pursuing marketing approval of the drug for the expanded access use with due diligence; and

(3)Evidence . (i) When the expanded access use is for a serious disease or condition, there is sufficient clinical evidence of safety and effectiveness to support the expanded access use. Such evidence would ordinarily consist of data from phase 3 trials, but could consist of compelling data from completed phase 2 trials; or

(ii) When the expanded access use is for an immediately life-threatening disease or condition, the available scientific evidence, taken as a whole, provides a reasonable basis to conclude that the investigational drug may be effective for the expanded access use and would not expose patients to an unreasonable and significant risk of illness or injury. This evidence would ordinarily consist of clinical data from phase 3 or phase 2 trials, but could be based on more preliminary clinical evidence.

(b)Submission . The expanded access submission must include information adequate to satisfy FDA that the criteria in 312.305(a)

Full text here: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=312.320

And then looking at CFR 312.305(a) we find:

(a)Criteria . FDA must determine that:

(1) The patient or patients to be treated have a serious or immediately life-threatening disease or condition, and there is no comparable or satisfactory alternative therapy to diagnose, monitor, or treat the disease or condition;

(2) The potential patient benefit justifies the potential risks of the treatment use and those potential risks are not unreasonable in the context of the disease or condition to be treated; and

(3) Providing the investigational drug for the requested use will not interfere with the initiation, conduct, or completion of clinical investigations that could support marketing approval of the expanded access use or otherwise compromise the potential development of the expanded access use.

(b)Submission . (1) An expanded access submission is required for each type of expanded access described in this subpart. The submission may be a new IND or a protocol amendment to an existing IND. Information required for a submission may be supplied by referring to pertinent information contained in an existing IND if the sponsor of the existing IND grants a right of reference to the IND.

Full text here: www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=312.305

So what could it mean?

It could mean that the FDA could grant commercial expanded access use for bavi under its existing IND without accelerated approval, breakthrough therapy designation, etc.

It means, we could be selling bavi this year.

Keep in mind Avid passed its most recent cGMP review in Feb. 2013 so they're good to go.