Avid Bioservices Inc (CDMO)

[biopharm]

Wouldn't BTD be a material event that needs to be reported?

So far many other biotechs/Big Pharma have not released any BTD granted by the FDA, within the material event alloted time of 4 business days. Companies have sat on Breakthrough Therapy Designation for periods of months without announcing it, and I'm sure they have done so because it was to their advantage and my guess is Peregrine wouldn't release it till they would be ready, if granted BTD by the FDA.

An FDA BTD will expedite the development and review of drugs for serious or life threatening conditions, offers the opporunity for financial incentives such as tax credits and user fee waivers..etc. More interesting is that certain FDA programs would allow big tax credits that would pay for the build out of manufacturing facility..etc..etc. Who knows, now with the build out expansion of Tustin facilities, Peregrine has a comparison value to go by for a much larger facility and tax credits they may be eligible for under other FDA programs that would pay for the build out of another site. (Big Pharma certainly does not like Peregrine preferred shares and also would not like little old Peregrine getting additional financial help to secure their path forward, with the expansion of the PS Targeting platform...)

A good question would be is it legal for the FDA to refuse to disclose an FOIA request for some form of information by a retail shareholder, and at the same time reveal that information to another person.... possibly a government employee or Senator or lobbyist..etc that requests the same information ??

http://www.accessdata.fda.gov/scripts/foi/FOIRequest/requestform.cfm?mode=A

------------------------------------------------------------

16) Will FDA announce when a drug has been granted breakthrough therapy designation?
FDA will not disclose information regarding sponsors who submitted requests for or who have been granted or denied breakthrough therapy designation. Breakthrough therapy designation requests are typically submitted to an IND, and the FDA cannot disclose the existence of an IND, or any submissions that have been submitted to the IND, unless it has previously been publicly disclosed or acknowledged per 21 CFR 312.130(a).

http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/SignificantAmendmentstotheFDCAct/FDASIA/ucm341027.htm

---------------------------------------------------

(d) The availability of information required to be publicly disclosed for investigations involving an exception from informed consent under § 50.24 of this chapter will be handled as follows: Persons wishing to request the publicly disclosable information in the IND that was required to be filed in Docket Number 95S-0158 in the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, shall submit a request under the Freedom of Information Act.
[52 FR 8831, Mar. 19, 1987. Redesignated at 53 FR 41523, Oct. 21, 1988, as amended at 61 FR 51530, Oct. 2, 1996; 64 FR 401, Jan. 5, 1999; 68 FR 24879, May 9, 2003]

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=312.130

-------------------------------------------------

...useful website included to track BTD's current as of 6/4/2015 included in this post

http://investorshub.advfn.com/boards/read_msg.aspx?message_id=94381305&txt2find=fda|btd

-------------------------------------------------

The designation is intended “to expedite the development and review of drugs for serious or life-threatening conditions,”

http://investorshub.advfn.com/boards/read_msg.aspx?message_id=94409253&txt2find=fda|btd

-----------------------------------------------

July 2, 2015

In addition, the FDA granted Orkambi orphan drug designation because it treats cystic fibrosis, a rare disease. Orphan drug designation provides financial incentives, like clinical trial tax credits, user fee waivers, and eligibility for market exclusivity to promote rare disease drug development.

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm453565.htm

----------------------------------------------------