Replies to post #119569 on Avid Bioservices Inc (CDMO)

[asmarterwookie]

Thanks FTM, sure supports reasoning that Peregrine applied...

“It really shouldn't cost them much in the way of resources to apply,” notes Milne, adding that a Tufts survey completed several years ago found that the average time spent by companies preparing Fast Track materials was about 60 hours. Such an average isn't available yet for the new classification, but it's likely to be a relatively small investment of time—one that could get a drug to market months, or even years, sooner."

The way Steven King, Dr. Garnick and Dr. Thorpe(rest his soul)et al...have talked about Bavituximab it would be shocking if they have not.

Bavituximab fits the bill.

wook

[EYEBUYSTOX]

As of March 15, there were 10 BTD given based on Margaret Hamburg's Massachusetts speech. Today, over a month later, only 7 have been made public. This delay from designation to announcement has occurred, without exception, to all BTDs given since last November. When I corresponded with the FDA's BTD office, they wouldn't elaborate on the process when I asked if the delay was due to additional information requested by the agency regarding manufacturing and commercialization strategies, etc. None of the BTD companies' IR departments would elaborate either. Until formal guidance is issued it seems as though we're going to be in the dark.

[sunstar]

I don’t think we have seen any data yet to say whether bavi has treated any ALK+ NSCLC patients in the: (1) signal seeking P2 trial, (2) the 2nd line NSCLC trial, (3) the front-line NSCLC trial or, (4) the bavi + Carbo + Pemetrexed NSCLC trial. My sense is that the broad spectrum character of bavi (anti-PS) would target any ALK+ patients easily.

Interesting that Novartis’ LDK378 may offer improved safety over Pfizer’s Crizotinib.

Between bavi’s well proven safety record and its strong efficacy, there may be a place for some immunotherapeutic input into the equation above.

IMO

sunstar