HIV was the primary reason of my investment, too - six years ago. However so much has happened since then including the successful results in NASH and mTNBC. For the last couple of years, I haven't been hanging my hat on the BLA submission, actually quite the opposite. Knowing the BLA still had not been submitted, and many were predicting it wouldn't be until sometime next year, it still would have taken another 6 months following submittal to get approval (we now know it would not have been) which means we wouldn't have seen any revenue for another year, and any revenue would have been minimal. My focus lately has been on a NASH and/or oncology partnerships, and as much it pains me to say this, I now agree that any potential partnership announcements won't happen until the partial hold is released by the FDA. Speaking of the FDA, I think withdrawing the BLA gives back our credibility within the eyes of the FDA that's been missing since the previous submittal (I also suspect it may have been at the FDA's suggestion). And knowing the BLA fiasco is now behind us (including the $80m that we paid Amarex and will hopefully recoup), I think mgmt is laser focused on submitting the required data and paperwork to the have the hold lifted, and hopefully it will be within the next couple of weeks/months. Afterwards, I expect to see a succession of PRs starting with an announcement about the lifting of the hold followed by partnership announcement(s) and then trial commencements. My guess, and I may have read this somewhere, is that Recknor has been working on the trial protocols (perhaps with potential partners) so they can be submitted to the FDA immediately after the hold is lifted, so that tells me they'll be locked and loaded. Now is not the time to be wringing one's hands over an old and incomplete BLA filing that we all knew had a 50/50 chance of success. The shorts may have a little fun with this next week, but any fluctuations in next week's share price will be in our rearview mirror as soon as the FDA lifts the hold, and that can happen any time.
Quote:It was the primary reason of my investment as well, but it was explained to me that an Approval for HIV combo was not even that significant
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My comments are just my opinions and should NOT be taken as investment advice.
