Replies to post #208063 on Biotech Values

[masterlongevity]

Would you consider it neutral, positive or very positive for $mnta? Thx in advance. No time to read until weekend

[DewDiligence]

PFNX issues silly PR commending FDA on its draft guidance re interchangeable FoBs:

http://www.pfenex.com/news/pfenex-statement-on-fda-release-of-draft-interchangeability-guidance/

The FDA took much longer than it should have to issue the (draft) guidance, so PFNX comes across as brown-nosing.

[DewDiligence]

Survey...Who will obtain FDA approval for any interchangeable FoB during the next 5 years?


Answer choices:
a) No one
b) Only MNTA (possibly with a partner)
c) Multiple companies


To vote, please go to
http://investorshub.advfn.com/boards/board_surveymenu.asp?board_id=1418
and select survey #165.

Note: The FDA’s draft guidance on interchangeable
FoBs can be found at the link in #msg-127909952.

[DewDiligence]

FDA extends comment period for interchangeable-FoB guidance by two months (until 5/19/17):

https://t.co/ViDJST1Kgs

Many comments are coming in, evidently.

[DewDiligence]

(MNTA)—Initial feedback to FDA’s draft guidance on interchangeable FoBs is coming in:

http://raps.org/Regulatory-Focus/News/2017/04/04/27266/FDA%E2%80%99s-Draft-Biosimilar-Interchangeability-Guidance-Stakeholders-Seek-More-Clarity/

The deadline for submitting comments is 5/19/17.